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Completed

NCT Number: NCT05783453

CLINICAL EFFICACY OF EMOLLIENTS IN ATOPIC DERMATITIS PATIENTS

his was a monocentric, intra-individual study, that was performed in at least 45 valid cases (50% children ≥3 YO; 50% adults). Study duration was 168 days with five (5) visits (D0, D14, D28, D84 and D168) to the research center.

Primary objective

* Evaluation of the efficacy of LIPIKAR BAUME LIGHT AP+M in decrease the SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use; * Evaluation of the efficacy of LIPIKAR BAUME LIGHT AP+M in maintenance the SCORAD value in child and adult subjects with mild atopic dermatitis after 84 and 168 days under normal conditions of use.

Secondary objective

* Evaluation of flares quantity and severity during 84 and 168 days of use; * Clinical evaluation of the improvement of skin parameters such as erythema, oedema, oozing, excoriation, lichenification, dryness and desquamation of a lesional and non-lesional skin from the same individual site by dermatologist after 14, 28, 84 and 168 days; * Self-assessment of the improvement of skin parameters such as itching, tingling, burning by subjects after 14, 28, 84 and 168 days; * Evaluate the perceived efficacy, cosmeticity and acceptability through a subjective evaluation questionnaire after 14, 28, 84 and 168 days; * Evaluation of the improvement in skin barrier function by the loss of transepidermic water through instrumental measurements with the Tewameter® equipment on AF and UAF after 14, 28, 84 and 168 days; * Evaluation of the improvement of skin moisturizing through instrumental measurements with Corneometer® equipment on AF and UAF after 14, 28, 84 and 168 days; * The folliculitis incidence after 14, 28, 84 and 168 days; * Assessment of the improvement of the impact of quality of life through a DLQI (Dermatology Life Quality Index) questionnaire after 14, 28, 84 and 168 days; * Assessment of global tolerance through clinical dermatological evaluation and reports performed by the subjects after using the product after 14, 28, 84 and 168 days. * Evaluation of total body skin dryness improvement after 14, 28, 84 and 168 days. * Illustrative clinical pictures of one or two affected areas.

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Key information

Who can participate

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

Inclusion criteria

  • Women or men, from 3 years old, being 50% children (≥3 years old ≤ 11 years and 11 months) and 50% adults;
  • All phototypes (a good balance between the phototypes is not mandatory, but all phototypes should be included);
  • Diagnosis of atopic dermatitis must meet Hanifin's criteria (at least 3 basic features and at least 3 minor features);
  • Subject with mild atopic dermatitis present for at least 6 months before inclusion (SCORAD at inclusion < 25);
  • Subjects that have an unchanged AD routine for at least 3 months, including to systematic use of topical or systemic antihistamines, topical or systemic corticoid, cyclosporin A and other immunosuppressant.
  • Subject able to use the study product at least once a day during all study.
  • Subject agreeing not to change their lifestyle during the study period (overbathing, being exposed to intense stress as change job, do a fast diet to loose weight…);
  • Subject agreeing to use only the study product and no other topical treatment for the duration of the study (usual topical or oral treatment for AD is allowed);
  • Subject capable of reading the documents presented to them, of adhering to the study regulations and accepting the limitations;
  • Subject available to follow the study;
  • Subject agreeing to participate and having signed the informed consent;
  • Subject available to be contacted by phone throughout the study.

Exclusion criteria

  • Breastfeeding, pregnant;
  • Subject presenting with another dermatological condition that could interfere with clinical evaluation;
  • Subject presenting a previous history of allergy to cosmetic products;
  • Subject having received any systemic treatment, including PUVA therapy for atopic dermatitis in the month prior to Day 0;
  • Subject having received phototherapy within 2 weeks before the first visit;
  • Subject who intend to excessively expose themselves to the sun during the study;
  • Subject known allergy to any component of the tested product (subjects will be asked if they have allergies to any ingredients and will be checked in the list if it is contained in the IP);
  • Subject who have used any experimental treatment within 2 weeks before the first visit;
  • Subject not presenting with the conditions needed to comply with the protocol;
  • Subject unable to give their informed consent;
  • Subject not available to follow the study in its entirety.

Treatment and study plan

Cosmetic study

Other

LIPIKAR BAUME LIGHT AP+M

  • Formula: 2039055 06
  • Aspect: Emulsion
  • Batch nº: RAUO0063
  • Expiry date: 10/2022
  • Application area: Face and Body
  • Application mode: Apply to face and body twice a day.
  • Quantity of product to be applied: About 1 flask (400g) per month

Other names: Emollient

Primary outcomes

  1. Improvement of SCORAD Score

    Time frame: baseline

    Decrease of SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use

  2. Improvement of SCORAD Score

    Time frame: Day 14

    Decrease of SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use

  3. Improvement of SCORAD Score

    Time frame: Day 28

    Decrease of SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use

  4. Improvement of SCORAD Score

    Time frame: Day 84

    Maintenance of SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use

  5. Improvement of SCORAD Score

    Time frame: Day 168

    Maintenance of SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use

Secondary outcomes

  1. Flares

    Time frame: Baseline

    Evaluation of flares quantity and severity on a scale 0=none to 4=severe

  2. Flares

    Time frame: Day 84

    Evaluation of flares quantity and severity on a scale 0=none to 4=severe

  3. Flares

    Time frame: Day 168

    Evaluation of flares quantity and severity on a scale 0=none to 4=severe

  4. Skin parameters

    Time frame: Baseline

    Improvement on a scale 0=none to 4=severe

  5. Skin parameters

    Time frame: Day 14

    Improvement on a scale 0=none to 4=severe

  6. Skin parameters

    Time frame: Day 28

    Improvement on a scale 0=none to 4=severe

  7. Skin parameters

    Time frame: Day 84

    Improvement on a scale 0=none to 4=severe

  8. Skin parameters

    Time frame: Day 156

    Improvement ona scale0=none to 4=severe

  9. Product acceptability

    Time frame: Day 14

    Subject questionnaire

  10. Product acceptability

    Time frame: Day 28

    Subject questionnaire

  11. Product acceptability

    Time frame: Day 84

    Subject questionnaire

  12. Product acceptability

    Time frame: Day 156

    Subject questionnaire

  13. Skin hydration

    Time frame: Baseline

    Transepidermal water loss using tewameter

  14. Skin hydration

    Time frame: Day 14

    Transepidermal water loss using tewameter

  15. Skin hydration

    Time frame: Day 28

    Transepidermal water loss using tewameter

  16. Skin hydration

    Time frame: Day 84

    Transepidermal water loss using tewameter

  17. Skin hydration

    Time frame: Day 156

    Transepidermal water loss using tewameter

  18. Skin moisturizing

    Time frame: Baseline

    Moisturising effect using corneometer

  19. Skin moisturizing

    Time frame: Day 14

    Moisturising effect using corneometer

  20. Skin moisturizing

    Time frame: Day 28

    Moisturising effect using corneometer

  21. Skin moisturizing

    Time frame: Day 84

    Moisturising effect using corneometer

  22. Skin moisturizing

    Time frame: Day 156

    Moisturising effect using corneometer

  23. Folliculitis

    Time frame: Baseline

    scale 0=none to 4=severe

  24. Folliculitis

    Time frame: Day 14

    scale 0=none to 4=severe

  25. Folliculitis

    Time frame: Day 28

    scale 0=none to 4=severe

  26. Folliculitis

    Time frame: Day 84

    scale 0=none to 4=severe

  27. Folliculitis

    Time frame: Day 156

    scale 0=none to 4=severe

  28. Evolution of Quality of life over time

    Time frame: Baseline

    DLQI (Dermatology Life Quality Index) questionnaire

  29. Evolution of Quality of life over time

    Time frame: Day 14

    DLQI (Dermatology Life Quality Index) questionnaire

  30. Evolution of Quality of life over time

    Time frame: Day 28

    DLQI (Dermatology Life Quality Index) questionnaire

  31. Evolution of Quality of life over time

    Time frame: Day 84

    DLQI (Dermatology Life Quality Index) questionnaire

  32. Evolution of Quality of life over time

    Time frame: Day 156

    DLQI (Dermatology Life Quality Index) questionnaire

  33. local tolerance reporting

    Time frame: Day 14

    reporting of events

  34. local tolerance reporting

    Time frame: Day 28

    reporting of events

  35. local tolerance reporting

    Time frame: Day 84

    reporting of events

  36. local tolerance reporting

    Time frame: Day 156

    reporting of events

  37. Total body dryness

    Time frame: Baseline

    scale

  38. Total body dryness

    Time frame: Day 14

    scale

  39. Total body dryness

    Time frame: Day 28

    scale

  40. Total body dryness

    Time frame: Day 84

    scale

  41. Total body dryness

    Time frame: Day 156

    scale

Sponsors and collaborators

Lead sponsor

Cosmetique Active International

Industry

Registry information

Official study title

CLINICAL EFFICACY OF EMOLLIENTS IN ATOPIC DERMATITIS PATIENTS: REDUCTION OF CRISES AND MAINTENANCE OF TREATMENT. STUDY UNDER NORMAL CONDITIONS OF USE AND DERMATOLOGICAL SUPERVISION

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 24, 2023
Registry last updated
Mar 24, 2023

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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