Evaluation of the Efficacy of a Dermocosmetic Product RT00401-GO0046 on Atopic Dermititis Severity in Subjects With Mild Atopic Dermatitis Versus Placebo

Pierre Fabre

Status: Active, not recruiting

Conditions: Atopic Dermatitis

Treatments: Other: RT00401-GO0046; Other: RT00401-GA0677

Study type: Observational

Funder types: Industry

Identifiers

NCT06763939

RT0040120240799

Details and patient eligibility

About

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.

Enrollment: 26 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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;

Trial design

26 participants in 1 patient group

Subjects with mild atopic dermatitis

Description:

This is an intra-individual study. The included subjects will apply both products, one on each side of target areas. The target areas can be located on both arms, both legs, both feet, both sides of lower back, or both sides of face (for women only) or lower back if the zones are clearly distinct and accessible for the products application. One of the identified areas will be tested with RT00401-GO0046 cream and the symmetric area will be tested with RT00401-GA0677 cream according to randomization. Not all study participants will apply the products to the same sides.

Treatment:

Other: RT00401-GA0677

Other: RT00401-GO0046