An observational study in Atopic Dermatitis, sponsored by Pierre Fabre Dermo Cosmetique. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-28.
Sponsored by Pierre Fabre Dermo Cosmetique · Observational
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:
This study will be conducted as an intra-individual, comparative, randomized, monocentric, investigator-blinded study, with 3 visits are planned:
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 32 is below the median of 150 across 237 observational studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Pierre Fabre Dermo Cosmetique is the lead sponsor of 58 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Main Inclusion criteria :
Main Non inclusion criteria
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
Cosmetic care product
Placebo cosmetic care product
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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: At the end of study, after last patient out, approximately 6 months after the beggining of the study.
Plan to share: No
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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Pierre Fabre Dermo Cosmetique