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Completed

NCT Number: NCT02925793

Safety and Efficacy Study of Topically Applied DS107 Cream in Mild to Moderate Atopic Dermatitis Patients (AD)

The purpose of this randomized, double blind, placebo controlled, parallel group study is to compare the safety and efficacy of topically applied DS107 cream (1% and 5%) versus vehicle cream, in the treatment of adult patients with mild to moderate Atopic Dermatitis (AD).

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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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

DS Biopharma Site, Markham, Canada

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About this study

This was a randomized, vehicle-controlled, double-blind, parallel-group, multicenter, Phase 2b study to investigate the safety and efficacy of topically administered DS107 cream and the dose-response relationship between DS107 cream and vehicle cream in patients 18 years and older with mild to moderate AD.

Approximately 300 patients (100 per treatment group), with mild to moderate AD were to be included in this study. All patients signed the patient information sheet (PIS)/informed consent form (ICF) and underwent screening for study eligibility. Eligible patients were randomized (1:1:1) to receive 1% DS107 cream, 5% DS107 cream or, vehicle cream:

Treatment Group A: 1% DS107 cream Treatment Group B: 5% DS107 cream Treatment Group C: Vehicle cream Study cream was to be applied topically to all affected or commonly affected areas twice daily (BID) for 8 weeks. To maintain the double-blind conditions, the DS107 and vehicle creams were identical in appearance. During their participation, patients were to come to the clinic on 7 occasions: Screening, Baseline, and at Weeks 2, 4, 6, 8 (end of treatment), and 10 (follow-up).

At the start of the study, areas for treatment were defined, DS107 or vehicle cream was then applied to those areas (and any newly affected areas) throughout the 8-week treatment period. Patients were instructed to apply the study cream liberally to the affected area in the morning and the evening. Emollients could be applied to other areas of dry skin that were not in the defined treatment area. On the days of clinic visits, patients were instructed to abstain from applying study cream for 6 hours prior to the visit and then to apply study cream as soon as possible after the clinic visit.

Once enrolled, patients were restricted from using any other treatment for AD. Any medication (prescription and over-the-counter [OTC] drugs) or therapeutic intervention deemed necessary for the patient, and which in the opinion of the investigator did not interfere with the safety and efficacy evaluations, could be continued unless they were included in the prohibited list of medications and therapeutic regimens.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with a clinically confirmed diagnosis of active Atopic Dermatitis according to Hanifin and Rajka criteria
  • Patients with mild to moderate Atopic Dermatitis at baseline as defined by an Investigator's Global Assessment (IGA) score of 3 or 2 at baseline visit
  • Patients with Atopic Dermatitis covering a minimum 5% of the body surface area at baseline
  • Male or female patients aged 18 years and older on the day of signing the informed consent form (ICF)

Exclusion criteria

  • Patients with other skin conditions that might interfere with Atopic Dermatitis diagnosis and/or evaluation (such as psoriasis or current active viral, bacterial and fungal topical skin infections) as assessed by the Investigator
  • Patients who have used systemic treatments (other than biologics) that could affect Atopic Dermatitis less that 4 weeks prior to baseline visit (Day 0), e.g. retinoids, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine and oral/injectable corticosteroids. Intranasal corticosteroids for stable medical conditions are allowed
  • Patients who have used any topical medicated treatment for Atopic Dermatitis two weeks prior to the start of treatment/baseline (Day 0) including but not limited to, topical corticosteroids, calcineurin inhibitors, tars, bleach, antimicrobials, and bleach baths
  • Patients who use topical products containing urea, ceramides or hyaluronic acid two weeks prior to Day 0
  • Patients who have a history of hypersensitivity to any substance in DS107 cream or vehicle cream
  • Patients who have any clinically significant controlled or uncontrolled medical condition or laboratory abnormality that would, in the opinion of the Investigator, put the patient at undue risk or interfere with the interpretation of study results
  • Patients with significant uncontrolled cardiovascular, neurologic, malignant, psychiatric, respiratory or hypertensive disease, as well as uncontrolled diabetes and floride arthritis or any other illness that, in the opinion of the Investigator, is likely to interfere with completion of the study
  • Patients with chronic infectious diseases (e.g. hepatitis B, hepatitis C, or infection with human immunodeficiency virus)

Treatment and study plan

DS107

Drug

Other names: 1%w/w DS107 DGLA Cream & 5%w/w DS107 DGLA Cream

Vehicle cream

Other

Other names: DS107 Placebo Cream

Primary outcomes

  1. Change From Baseline in Numeric Rating Scale (NRS) for Pruritus in Treated Population Compared to Vehicle Population at Week 8

    Time frame: Baseline and Week 8

    Change from baseline in Numeric Rating Scale (NRS) for Pruritus in treated population compared to vehicle population at Week 8. Severity of pruritus related to atopic dermatitis (AD) was self-assessed by patients daily using the NRS. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. The Pruritus NRS is a single-question assessment tool that was used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients scored their pruritus due to AD on a scale of 0 - 10, with 0 indicating no itch and 10 indicating the worst itch imaginable. Patients were required to complete the rating scale daily starting at screening through to the last study visit. A decrease in worst itch NRS indicates a positive outcome for the participant.

  2. Change From Baseline in Eczema Area and Severity Index (EASI) in Treated Population Compared to Vehicle Population at Week 8

    Time frame: Baseline and Week 8

    Change from baseline in EASI in treated population compared to vehicle population at Week 8. EASI quantifies the severity of a patient's atopic dermatitis (AD) based on both lesion severity and the percent of body surface area (BSA) affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):

    • 0 = none
    • 1 = mild
    • 2 = moderate
    • 3 = severe A decrease in EASI indicates a positive outcome for the participant.

Secondary outcomes

  1. Change From Baseline in NRS for Pruritus Intreated Populations Compared to Vehicle Population at Week 2, 4, 6, 10

    Time frame: Baseline, Week 2, Week 6 and Week 10

    Change from baseline in NRS for Pruritus in the treated populations compared to vehicle population at Weeks 2, 4, 6, 10. Severity of pruritus related to atopic dermatitis (AD) was self-assessed by patients daily using the NRS. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. The Pruritus NRS is a single-question assessment tool that was used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients will score their pruritus due to AD on a scale of 0 - 10, with 0 indicating no itch and 10 indicating the worst itch imaginable. Patients were asked to complete the rating scale daily starting at screening through to the last study visit. A decrease in worst itch NRS indicates a positive outcome for the participant.

  2. Proportion of Patients Achieving a Decrease of at Least 2.7 Points in NRS in the Treated Populations Compared to Vehicle Population From Baseline to Weeks 2, 4, 6, 8, and 10.

    Time frame: 10 weeks

    • Proportion of Patients Achieving a Decrease of at Least 2.7 Points in Numeric Rating Scale (NRS) in Treated Population Compared to Vehicle Population from Baseline to Week 2, 4, 6, 8 and 10. The NRS for Pruritus is a single-question assessment tool that was used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. Patients were to score their pruritus due to AD on a scale of 0-10, with 0 (no itch) and 10 (worst itch imaginable)

  3. Change From Baseline in EASI in Treated Population Compared to Vehicle Population at Weeks 2, 4, 6, 10.

    Time frame: Baseline, Week 2, Week 4, Week 6 and Week 10

    Change from baseline in EASI in the treated populations compared to vehicle population at Weeks 2, 4, 6, 10. EASI quantifies the severity of a patient's atopic dermatitis (AD) based on both lesion severity and the percent of body surface area (BSA) affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):

    • 0 = none
    • 1 = mild
    • 2 = moderate
    • 3 = severe A decrease in EASI indicates a positive outcome for the participant.

  4. Proportion of Patients Achieving an Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA in Treated Population Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10.

    Time frame: 10 weeks

    Proportion of patients achieving an IGA score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in IGA in treated population compared to vehicle population from baseline to Week 2, 4, 6, 8, 10. EASI quantifies the severity of a patient's atopic dermatitis (AD) based on both lesion severity and the percent of body surface area (BSA) affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):

    • 0 = none
    • 1 = mild
    • 2 = moderate
    • 3 = severe A decrease in EASI indicates a positive outcome for the participant.

  5. Proportion of Patients Achieving a Decrease of at Least 2 Points in IGA in the Treated Populations Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10.

    Time frame: 10 weeks

    Proportion of Patients Achieving a Decrease of at Least 2 Points in Investigator Global Assessment (IGA) in the Treated Populations Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10.

    The IGA scale awards a score of 0˗4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). IGA uses clinical characteristics of erythema, infiltration, papulation, and oozing/crusting as scoring guidelines for the overall severity assessment.

  6. Change From Baseline in IGA Score in the Treated Populations Compared to Vehicle Population at Weeks 2, 4, 6, 8, 10.

    Time frame: Baseline, Week 2, Week 4, Week 6, Week 8 and Week 10

    The Global Investigator Assessment scale (IGA) scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3

    = moderate disease, 4 = severe disease). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.

Sponsors and collaborators

Lead sponsor

DS Biopharma

Industry

Registry information

Official study title

A Randomised, Double-blind, Vehicle-Controlled, Phase IIb Study to Assess the Efficacy and Safety of Topically Applied DS107 Cream to Adults With Mild to Moderate Atopic Dermatitis

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 6, 2016
Registry last updated
Nov 22, 2022

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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