Clinical trial NCT06763939: Evaluation of the Efficacy of a Dermocosmetic Product RT00401-GO0046 on Atopic Dermititis Severity in Subjects With Mild Atopic Dermatitis Versus Placebo
Official title: A Randomized, Comparative, Investigator-blinded Study to Evaluate the Efficacy of a Dermocosmetic Product RT00401 - Formula: GO0046 on Atopic Dermititis Severity in Subjects With Mild Atopic Dermatitis Versus Placebo.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atopic Dermatitis
Lead sponsor: Pierre Fabre Dermo Cosmetique
Sponsor class: INDUSTRY
First posted: 2025-01-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the investigation centre's panel. They will be selected on the basis of inclusion and non-inclusion criteria specific to the study and on their ability to comply with the constraints required by the protocol. They will be definitely included in the study after a specific interview and a clinical examination.

Brief summary: The aim of this study is to evaluate the RT00401- GO0046 formula on atopic dermititis severity in subjects with mild atopic dermatitis versus placebo on 26 subjects.

The objectives of this study are:

* To evaluate the clinical efficacy of the RT00401-GO0046 cream compared to RT00401-GA0677 placebo cream on AD severity of tested areas and flare-up onset.
* To evaluate the effect of the RT00401-GO0046 cream on microbiota diversity and other pharmaco-clinical biomarkers with respective techniques on skin surface in subjects with AD compared to the effect of the RT00401-GA0677 placebo cream.
* To illustrate the effect of the RT00401-GO0046 cream with photos of the tested areas.

This study will be conducted as an intra-individual, comparative, randomized, monocentric, investigator-blinded study, with 3 visits are planned:

* Visit 1 (D1): Inclusion and 1st products application
* Visit 2 (D29 +/- 2 days): 1-month follow-up visit
* Visit X (Suspected flare-up +/- 2 days): End-of-study visit if AD flare-up is confirmed
* Visit 3 (D85 +/- 3 days): End-of-study visit This clinical study is designed as an investigator-blinded study. Participants will be required to apply two different products, one on each side: Product A and Product B. One of these products is the "test product" RT00401 Formula GO0646, and the other is the "control product" RT00401 Formula GA0677. However, participants will not know which product is which. The randomization will determine the side on which each product is applied (Product A on the right and Product B on the left, or vice versa). The product tubes will be identical, ensuring that neither the participants nor the investigator will know which product is the test product or the control product. This blinding ensures that neither the participants nor the investigator will be influenced by the nature of the products applied, thereby enhancing the robustness and objectivity of the study results.


Eligibility criteria: Main Inclusion criteria :

* Female and/or male;
* Subject aged ≥ 18 years;
* Subjects presenting atopic dermatitis according to the definition of "the U.K Working Party's Diagnostic Criteria for Atopic Dermatitis";
* Subject presenting a mild AD with a SCORAD from 15 to 20 with dryness evaluation parameter ≥ 2 at inclusion;
* Based on the subject's statements regarding their skin condition history:
* Subject with AD symmetric lesions, size from 10 to 15 cm² on both target areas;
* Subject who will likely present a flare-up during their participation according to investigator's opinion;

Main Non inclusion criteria

* Subject whose skin condition in the potential target areas is contact eczema or dyshidrotic eczema rather than atopic dermatitis (particularly on feet).
* Subject having any other dermatologic condition than Atopic Dermatitis, or characteristics (like tattoo) on the tested areas, liable to interfere with the study assessments according to investigator opinion;
* Subject having significant hair growth on tested areas;
* Subject presenting a flare-up at time of inclusion visit requiring a therapeutic care;

Primary outcomes:
measure: Evaluation of SCORAD
timeFrame: At baseline (Day 1) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
measure: Evaluation of L-SCORAD
timeFrame: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
measure: Evaluation of L-PO SCORAD
timeFrame: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
measure: Evolution of pruritus sensations using numerical rating scale (NRS)
timeFrame: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
measure: Microbiota diversity
timeFrame: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
measure: Metabolomic features
timeFrame: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
measure: Cytokine panel
timeFrame: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
measure: Transepidermal water loss measurments by tewameter®
timeFrame: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
measure: Skin pH measurements by phmeter
timeFrame: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
measure: Investigator Global Assessment (IGA)
timeFrame: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
measure: Patient Global Assessment (PGA)
timeFrame: At baseline (Day 1), at Visit 2 (Day 29) and at the final visit (Day 85 or Day X if the flare-up of AD is confirmed before Day 85),
measure: Atopic dermititis severity by counting of flare-up onset
timeFrame: At the end of study, after last patient out, approximately 6 months after the beggining of the study.
Secondary outcomes:
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Dermscan Poland
Study officials:
References: