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OpenTrials
Completed

NCT Number: NCT04447417

Dupilumab Skin Barrier Function Study in Atopic Dermatitis

Primary Objective:

- Evaluate changes in skin barrier function with transepidermal water loss (TEWL) assessed after skin tape stripping (STS) in pre-defined lesional skin in participants with moderate to severe atopic dermatitis (AD) treated with dupilumab.

Secondary Objectives:

* Evaluate changes in skin barrier function with TEWL assessed after STS in pre-defined lesional and non-lesional skin in participants with moderate to severe AD treated with dupilumab in reference to normal skin of healthy volunteers. * Evaluate time course of skin barrier function with TEWL assessed before and after STS in pre-defined lesional and non-lesional skin in participants with moderate to severe AD treated with dupilumab in reference to normal skin of healthy volunteers.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigational Site Number 1240001, Montreal, Canada

Loading trial locations.

About this study

The duration for each participant was a total of approximately 24 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant must be between 12 to 65 years of age (inclusive), at the time of signing the informed consent.

Atopic dermatitis participants:

  • Male or female participants.
  • Participants with AD diagnosis according to Hanifin and Rajka criteria at least 1 year before screening.
  • Investigator Global Assessment score of >=3 at screening (on the 0-4 scale).
  • Participants with moderate to severe atopic dermatitis that were eligible to be treated with dupilumab according to product monograph.
  • Participants with AD must have had active lesions on the upper limbs or lower limbs, with severity for lesion erythema or edema/papulation >=2 at screening on the 0-3 scale of the individual signs score.
  • Patients must have had a non-lesional (normal looking) skin area 4 centimeters from the edge of the lesional area.
  • Were willing to refrain from applying any topical medication products on the target assessment areas (including lesional and non-lesional) throughout the study unless necessary to alleviate intolerable symptoms.
  • Were willing to refrain taking showers or soaking in a bathtub with soaps and body washes within 6 hours before TEWL assessments.
  • Were willing to apply Cetaphil or Vanicream moisturizer up to twice a day with an exception of moisturizer application on the targeted assessment areas (lesional and non-lesional areas) during the entire study from Day -7 to end of treatment.
  • Were willing and able to comply with all clinic visits and study-related procedures.

Healthy volunteers:

  • Age and gender matched to a selected AD participant. Adolescents aged 12 to 17 years matched by post puberty status, and adults aged 18 to 65 years were matched by age as close as possible within 10 years of age.
  • No current dermatologic or systemic condition that could interfere with the assessments.
  • Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Capable of understanding and giving signed informed consent/assent as were described in the protocol, which included compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. For adolescents >=12 and <18 years of age a specific ICF must also be signed by the participant's legally authorized representative.

Exclusion criteria

  • Skin conditions other than AD that can confound assessments in the area of TEWL assessments in the opinion of the investigator (i.e., skin atrophy, ichthyosis, Netherton syndrome, severe photo damage).
  • Cracked, crusted, oozing, or bleeding AD lesions in the designated lesional assessment area leaving insufficient skin that was adequate for TEWL assessments.
  • Hypersensitivity to the active substance or to any of the excipients of dupilumab.
  • Ocular disorder that in the opinion of the investigator could adversely affect the individual's risk for study participation. Examples include -but are not limited to- individuals with a history of active cases of herpes keratitis; Sjogren's syndrome, keratoconjunctivitis sicca or dry eye syndrome that required daily use of supplemental lubrication; or individuals with ocular conditions that required the use of ocular corticosteroids or cyclosporine.
  • Systemic AD treatment or phototherapy within 4 weeks of Baseline.
  • Topical AD treatment within 1 week of Baseline. Face and neck may be treated with topical steroids during the washout period if approved by the investigator.
  • Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the participant's participation in the study. Examples included, but were not limited to participants with short life expectancy, participants with uncontrolled diabetes (hemoglobin A1c >=9%), participants with cardiovascular conditions (eg, Class III or IV cardiac failure according to the New York Heart Association classification), severe renal conditions (eg, participants on dialysis), hepato-biliary conditions (eg, Child-Pugh class B or C), neurological conditions (eg, demyelinating diseases), active major autoimmune diseases (eg, lupus, inflammatory bowel disease, rheumatoid arthritis, etc.), other severe endocrinological, gastrointestinal, metabolic, pulmonary, psychiatric (known suicidal intentions) or lymphatic diseases. The specific justification for participants excluded under this criterion were noted in study documents (chart notes, electronic case report forms, screening logs, etc.).
  • History of hypersensitivity reaction to tape or adhesives.
  • Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known) prior to Day 1, whichever was longer.
  • Current participation in another investigational clinical study.
  • Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who were legally institutionalized.
  • Participants were dependent on the Sponsor or Investigator (in conjunction with section 1.61 of the ICH-GCP Ordinance E6).
  • Individuals directly involved in the conduct of the study, or immediate family members of such individuals.
  • Any specific situation during study implementation/course that might rise ethics considerations.
  • Planned or anticipated major surgical procedure during the participant's participation in this study.
  • Pregnant or breast feeding women, or were planning to become pregnant or breastfeed during the participant's participation in this study.
  • Women unwilling to use adequate birth control, if of reproductive potential* and sexually active. Adequate birth control was defined as agreement to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 12 weeks after last dose of study drug. These included condom, spermicide, hormonal contraceptives, intrauterine device, or double barrier contraception (i.e., condom + diaphragm) or a male partner with documented vasectomy. Additional requirements for acceptable contraception might apply in certain countries, based on local regulations. Investigators in these countries were notified accordingly in a protocol clarification letter.

*For females, menopause was defined as at least 12 consecutive months without menses; if in question, a follicle stimulating hormone level of >=25 milliunits per milliliter must be documented. Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be documented, as applicable; if documented, women with these conditions were not required to use additional contraception.

  • Healthy volunteers with a personal history of an atopic condition.
  • Healthy volunteers with use of any topical treatment anywhere except Cetaphil or Vanicream moisturizer on non-targeted skin areas.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Treatment and study plan

Dupilumab SAR231893

Drug

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Other names: REGN668

Primary outcomes

  1. Percent Change From Baseline in Transepidermal Water Loss After 5 Skin Tape Stripping (STS) on Lesional Skin (LS) in AD Patients at Week 16

    Time frame: Baseline, Week 16

    TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize skin barrier function (SBF). TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. Lesional skin (LS) areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within the predefined LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent Change from Baseline at Week 16 in TEWL after 5 STS on LS (first spot) in AD participants were reported in this outcome measure (OM). Here, overall number of participants analyzed=participants evaluable for this OM.

Secondary outcomes

  1. Percent Change From Baseline in TEWL After 20 STS on Lesional and Non-lesional Skin (Non-LS) in AD Patients at Week 16

    Time frame: Baseline, Week 16

    TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS and non-LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from Baseline at Week 16 in TEWL after 20 STS on LS and non-LS (first spot) in AD participants were reported in this OM.

  2. Absolute Change in TEWL After 20 STS on Lesional and Non-lesional Skin in AD Patients at Week 16

    Time frame: Baseline, Week 16

    TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS and non-LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from Baseline at Week 16 in TEWL after 20 STS on LS and non-LS (first spot) in AD participants were reported in this OM.

  3. Percent Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16

    Time frame: Baseline, Week 16

    TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from Baseline at Week 16 in TEWL after 20 STS on normal skin (first spot) in healthy volunteers were reported in this OM.

  4. Absolute Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16

    Time frame: Baseline, Week 16

    TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from Baseline at Week 16 in TEWL after 20 STS on normal skin (first spot) in healthy volunteers were reported in this OM.

  5. Percent Change From Baseline in TEWL After 15 STS on Lesional and Non-lesional Skin in AD Patients at Week 16

    Time frame: Baseline, Week 16

    TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS and non-LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from Baseline at Week 16 in TEWL after 15 STS on LS and non-LS (first spot) in AD participants were reported in this OM.

  6. Absolute Change From Baseline in TEWL After 15 STS on Lesional and Non-lesional Skin in AD Patients at Week 16

    Time frame: Baseline, Week 16

    TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS and non-LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from Baseline at Week 16 in TEWL after 15 STS on LS and non-LS (first spot) in AD participants were reported in this OM.

  7. Percent Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16

    Time frame: Baseline, Week 16

    TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from Baseline at Week 16 in TEWL after 15 STS on normal skin (first spot) in healthy volunteers were reported in this OM.

  8. Absolute Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16

    Time frame: Baseline, Week 16

    TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from Baseline at Week 16 in TEWL after 15 STS on normal skin (first spot) in healthy volunteers were reported in this OM.

  9. Percent Change From Baseline in TEWL After 10 STS on Lesional and Non-lesional Skin in AD Patients at Week 16

    Time frame: Baseline, Week 16

    TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS and non-LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from Baseline at Week 16 in TEWL after 10 STS on LS and non-LS (first spot) in AD participants were reported in this OM.

  10. Absolute Change From Baseline in TEWL After 10 STS on Lesional and Non-lesional Skin in AD Patients at Week 16

    Time frame: Baseline, Week 16

    TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS and non-LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from Baseline at Week 16 in TEWL after 10 STS on LS and non-LS (first spot) in AD participants were reported in this OM.

  11. Percent Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16

    Time frame: Baseline, Week 16

    TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from Baseline at Week 16 in TEWL after 10 STS on normal skin (first spot) in healthy volunteers were reported in this OM.

  12. Absolute Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16

    Time frame: Baseline, Week 16

    TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from Baseline at Week 16 in TEWL after 10 STS on normal skin (first spot) in healthy volunteers were reported in this OM.

  13. Absolute Change From Baseline in TEWL After 5 STS on Lesional Skin in AD Patients at Week 16

    Time frame: Baseline, Week 16

    TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from Baseline at Week 16 in TEWL after 5 STS on LS (first spot) in AD participants were reported in this OM.

  14. Percent Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Patients at Week 16

    Time frame: Baseline, Week 16

    TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from Baseline at Week 16 in TEWL after 5 STS on non-LS (first spot) in AD participants were reported in this OM.

  15. Absolute Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Patients at Week 16

    Time frame: Baseline, Week 16

    TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined non-LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from Baseline at Week 16 in TEWL after 5 STS on non-LS (first spot) in AD participants were reported in this OM.

  16. Percent Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16

    Time frame: Baseline, Week 16

    TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Percent change from Baseline at Week 16 in TEWL after 5 STS on normal skin (first spot) in healthy volunteers were reported in this OM.

  17. Absolute Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16

    Time frame: Baseline, Week 16

    TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. The normal skin areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on first spot. Absolute change from Baseline at Week 16 in TEWL after 5 STS on normal skin (first spot) in healthy volunteers were reported in this OM.

  18. Percent Change From Baseline in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16

    Time frame: Baseline, Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16

    TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. LS and non-LS areas for TEWL assessment were identified at Baseline ('predefined skin area'). Within predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). TEWL was measured prior to STS on pre-defined LS and non-LS areas at specified time points. At each visit, before STS, all three spots were assessed, and their value was averaged to derive a single value. Percent change from Baseline at specified time points in TEWL before STS on LS and non-LS in AD participants were reported in this OM.

  19. Absolute Change From Baseline up to Week 16 in TEWL Before STS on Lesional and Non-lesional Skin in AD Patients at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16

    Time frame: Baseline, Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16

    TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. LS and non-LS areas for TEWL assessment were identified at Baseline ('predefined skin area'). Within predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). TEWL was measured prior to STS on pre-defined LS and non-LS areas at specified time points. At each visit, before STS, all three spots were assessed, and their value was averaged to derive a single value. Absolute change from Baseline at specified time points in TEWL before STS on LS and non-LS in AD participants were reported in this OM.

  20. Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16

    Time frame: Baseline, Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16

    TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. Normal skin areas for TEWL assessment were identified at Baseline ('predefined skin area'). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined normal skin areas at specified time points. At each visit, before STS, all three spots were assessed, and their value was averaged to derive a single value. Percent change from Baseline at specified time points in TEWL before STS on normal skin in healthy volunteers were reported in this OM.

  21. Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16

    Time frame: Baseline, Day 4, 8, 11, 15, 22, 29, 43, 57, 85 and Week 16

    TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. Normal skin areas for TEWL assessment were identified at Baseline ('predefined skin area'). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS on pre-defined normal skin areas at specified time points. At each visit, before STS, all three spots were assessed, and their value was averaged to derive a single value. Absolute change from Baseline at specified time points in TEWL before STS on normal skin in healthy volunteers were reported in this OM.

  22. Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16

    Time frame: Baseline, Day 15, 29, 57, 85 and Week 16

    TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. LS and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS and non-LS areas at specified time points. STS assessment was done at Baseline (Week 0, Day 1), Day 57 and Week 16 on 1st spot; at Day 15 on 2nd spot and at Day 29 and Day 85 on 3rd spot. Percent change from Baseline at specified time points in TEWL after STS on LS and non-LS in AD participants were reported in this OM.

  23. Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16

    Time frame: Baseline, Day 15, 29, 57, 85 and Week 16

    TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. LS and non-LS areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). TEWL: measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS and non-LS areas at specified time points. STS assessment was done at Baseline (Week 0, Day 1), Day 57 and Week 16 on 1st spot; at Day 15 on 2nd spot and at Day 29 and Day 85 on 3rd spot. Absolute change from Baseline at specified time points in TEWL after STS on LS and non-LS in AD participants were reported in this OM.

  24. Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16

    Time frame: Baseline, Day 15, 29, 57, 85 and Week 16

    TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Normal skin areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment was done at Baseline (Week 0, Day 1), Day 57 and Week 16 on 1st spot; at Day 15 on 2nd spot and at Day 29 and Day 85 on 3rd spot. Percent change from Baseline at specified time points in TEWL after STS on normal skin in healthy volunteers were reported in this OM.

  25. Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16

    Time frame: Baseline, Day 15, 29, 57, 85 and Week 16

    TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. With STS, uppermost layers of skin are peeled away using adhesive discs. Normal skin areas for TEWL assessment and STS were identified at Baseline ('predefined skin area'). Within predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined normal skin areas at specified time points. STS assessment was done at Baseline (Week 0, Day 1), Day 57 and Week 16 on 1st spot; at Day 15 on 2nd spot and at Day 29 and Day 85 on 3rd spot. Absolute change from Baseline at specified time points in TEWL after STS on normal skin in healthy volunteers were reported in this OM.

  26. Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16

    Time frame: Baseline, Day 15, 29, 57, 85 and Week 16

    TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS was used to reflect the overall integrity of the stratum corneum. LS and non-LS areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within the predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS and non-LS areas at specified time points. TEWL AUC was a composite measure before and after 5, 10, 15 and 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal rule. Percent change from Baseline at specified time points in TEWL AUC in AD participants were reported in this OM.

  27. Absolute Change From Baseline in Area Under the Curve of TEWL on Lesional and Non-lesional Skin in AD Patients at Day 15, 29, 57, 85 and Week 16

    Time frame: Baseline, Day 15, 29, 57, 85 and Week 16

    TEWL assessment: noninvasive in vivo measurement of water loss across stratum corneum, used to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS was used to reflect overall integrity of the stratum corneum. LS and non-LS areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within predefined LS and non-LS areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment (3 spots on LS, 3 spots on non-LS). TEWL was measured prior to STS and after 5,10,15 and 20 STS on pre-defined LS and non-LS areas at specified time points. TEWL AUC was a composite measure before and after 5, 10, 15 and 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal rule. Absolute change from Baseline at specified time points in TEWL AUC in AD participants were reported in this OM. Expanded unit of measure is number of skin tape stripping*grams per square meter per hour.

  28. Percent Change From Baseline in Area Under the Curve of TEWL on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16

    Time frame: Baseline, Day 15, 29, 57, 85 and Week 16

    TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS was used to reflect the overall integrity of the stratum corneum. Normal skin areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL measured prior to STS and after 5,10,15 and 20 STS on pre-defined normal skin areas at specified time points. TEWL AUC was a composite measure before and after 5, 10, 15 and 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal rule. Percent Change from Baseline at specified time points in TEWL AUC in healthy volunteers were reported in this OM.

  29. Absolute Change From Baseline in TEWL Area Under the Curve (AUC) on Normal Skin in Healthy Volunteers at Day 15, 29, 57, 85 and Week 16

    Time frame: Baseline, Day 15, 29, 57, 85 and Week 16

    TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize SBF. TEWL combined with STS measures SBF. TEWL AUC done over defined number of STS was used to reflect the overall integrity of the stratum corneum. Normal skin areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within the predefined normal skin areas, 3 closely adjacent non-overlapping spots identified for subsequent SBF assessment. TEWL measured prior to STS and after 5,10,15 and 20 STS on pre-defined normal skin areas at specified time points. TEWL AUC was a composite measure before and after 5, 10, 15 and 20 STS at each specified time point. AUC of TEWL: calculated for each visit using trapezoidal rule. Absolute change from Baseline at specified time points in TEWL AUC in healthy volunteers were reported in this OM. Expanded unit of measure is number of skin tape stripping*grams per square meter per hour.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

Open Label Exploratory Study to Evaluate the Effect of Dupilumab on Skin Barrier Function in Patients With Moderate to Severe Atopic Dermatitis

Acronym: BALISTAD

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 25, 2020
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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