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

NCT06763939 | Completed

• 1 other identifier: RT0040120240799
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (12)

• Evaluation of SCORAD

  an examination of the face and body of the subject is carried out by the dermatologist in charge of the study to evaluate the initial intensity of atopic dermatitis by determination of SCORAD index

  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),

• Evaluation of L-SCORAD

  The Local SCORAD is the evaluation of the objective parameters of the SCORAD will be assessed independently on both target areas by the Investigator

  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),

• Evaluation of L-PO SCORAD

  The Local PO SCORAD will be evaluated by the subjects independently on the same target areas that L-SCORAD

  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),

• Evolution of pruritus sensations using numerical rating scale (NRS)

  The subject will realize auto-scoring of pruritus independently on both target areas perceived (with average intensity over the last 3 days) using a Numeric Rating Scale from 0 (no pruritus) to 10 (severe discomfort sensations).

  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),

• Microbiota diversity

  A total of 18 cutaneous samples per subject: 3 by cotton-swab samples per sampling area per time point will be taken at each study visit, on the study areas (identified at inclusion visit), will be carried out for analyses

  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),

• Metabolomic features

  A total of 18 cutaneous samples per subject: 3 by cotton-swab samples per sampling area per time point will be taken at each study visit, on the study areas (identified at inclusion visit), will be carried out for analyses

  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),

• Cytokine panel

  A total of 18 cutaneous samples per subject: 3 by cotton-swab samples per sampling area per time point will be taken at each study visit, on the study areas (identified at inclusion visit), will be carried out for analyses

  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),

• Transepidermal water loss measurments by tewameter®

  A trans-epidermal water loss will be measured with a Tewameter TM 300® independently on both target areas

  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),

• Skin pH measurements by phmeter

  A cutaneous pH level will be measured with a COURAGE \& KHAZAKA PH 900 PC Skin pHmeter® fitted with an Ingold® electrode independently on both target areas

  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),

• Investigator Global Assessment (IGA)

  IGA will be assessed by the investigator independently on both target areas perceived at each study visit from Visit 2, compared to Visit 1, according to a 5-point scale: 0= worse, 1= no change, 2= slight improvement, 3= marked improvement; 4= total resolution Local IGA assesses the evolution of target areas AD basing on objective signs (erythema, oedema/papulation, oozing/crusts, excoriation, lichenification, dryness) compared to baseline (Visit 1).

  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),

• Patient Global Assessment (PGA)

  PGA will be assessed by the subjects independently on both target areas perceived at each study visit from Visit 2, compared to Visit 1, according to a 5-point scale: 0= worse 1= no change, 2= slight improvement, 3= marked improvement; 4= total resolution Local PGA assesses the evolution of target areas AD intensity compared to baseline (Visit 1).

  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),

• Atopic dermititis severity by counting of flare-up onset

  At the end of the study, the number of flare-ups that occurred during the study will be evaluated

  At the end of study, after last patient out, approximately 6 months after the beggining of the study.

Study Arms (1)

Subjects with mild atopic dermatitis

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.

Other: RT00401-GO0046; Other: RT00401-GA0677

Interventions

RT00401-GO0046 OTHER

Cosmetic care product

Subjects with mild atopic dermatitis

RT00401-GA0677 OTHER

Placebo cosmetic care product

Subjects with mild atopic dermatitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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";
• 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;
• 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;

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Dermscan Poland

Gdansk, Poland, 80288, Poland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Swab samplings on skin

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 8, 2025
• Study Start: February 17, 2025
• Primary Completion: June 24, 2025
• Study Completion: June 24, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)