An interventional study of Emollient cream RV4660B in Atopic Dermatitis (AD), sponsored by Pierre Fabre Dermo Cosmetique. Completed at 1 site in Brazil. Open to participants aged 2 Months to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Pierre Fabre Dermo Cosmetique (part of Pierre Fabre) · Not applicable, Interventional, and Other
The aim of this study is to evaluate the efficacy and tolerance of a face and body emollient cream in individuals (infants, children, adults) with phototypes IV-VI presenting mild to moderate atopic dermatitis (study under dermatological control)
This study is conducted as a single-center, open-labeled study in Latin America. A total of 59 subjects are enrolled in the study. Assessments are performed at Day 1, Day 8 and Day 29.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's enrollment of 59 is below the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Pierre Fabre Dermo Cosmetique is the lead sponsor of 59 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
INCLUSION CRITERIA:
Age as presented below:
Phototypes IV-VI according to the Fitzpatrick scale following the distribution bellow:
All enrolled subjects (infants, children and adults) with atopic dermatitis and phototypes IV-VI (Fitzpatrick scale) receive the tested emollient cream applied once daily for 4 weeks.
Other: Emollient cream RV4660B
Emollient cream, applied once daily to face and body for a period of 4 weeks.
Atopic Dermatitis Severity by the investigator- SCORAD (SCORing Atopic Dermatitis)
Evolution of the SCORAD assessed by the Investigator at each visit
Time frame: Visit 1 (Day 1 - baseline), Visit 2 (Day8) To Visit 3 (Day 29)
Atopic Dermatitis Severity by the investigator- L-SCORAD (Local SCORing Atopic Dermatitis)
Evolution of the Local-SCORAD assessed by the Investigator at each visit on a target area (= area most representative of Atopic Dermatitis severity of the entire body)
Time frame: Visit 1 (Day 1 - baseline), Visit 2 (Day8) To Visit 3 (Day 29)
Atopic Dermatitis Severity by the subject- PO-SCORAD (Patient-Oriented SCORing Atopic Dermatitis)
Evolution of the PO-SCORAD self-assessed by the subject or parent's)/legal representative at each visit
Time frame: Visit 1 (Day 1 - baseline), Visit 2 (Day8) and Visit 3 (Day 29)
Discomfort sensations
Evolution of discomfort self-assessed by the subject or parent's)/legal representative using a Numerical Rating Scale (NRS, 0-10; 0 = no symptom, 10 = worst imaginable symptom)
Time frame: Visit 1 (Day 1 - baseline), Visit 2 (Day8) and Visit 3 (Day 29)
Dermatological tolerance of the tested product
Tolerance assessed by the Investigator at each study visit. The results will take into account the clinical signs observed by the investigators and the signs reported by the subject based on a 5-point scale (From 1 = Excellent tolerance to 5 = Bad tolerance)
Time frame: Visit 1 (Day 1 - baseline), Visit 2 (Day8) and Visit 3 (Day 29)
Quality of life questionnaire
Quality of life self-assessed by the subject or parent's)/legal representative by completing the Dermatology Life Quality Index (DLQI) or Children's Dermatology Life Quality Index (CDLQI) or Infant Dermatology Quality of Life Index (IDQOL) questionnaire according to the subject age
Time frame: From Visit 1 (Day 1 - baseline) To Visit 3 (Day 29)
Atopic dermatitis disease control
Atopic dermatitis disease control self-assessed by the subject or parent's)/legal representative by completing the ADCT (Atopic Dermatitis Control Tool) questionnaire. The outcome measure assesses AD control over the past week, including symptom frequency and impact on daily activities. Total score ranges from 0 to 24; a score ≥ 7 indicates inadequately controlled AD.
Time frame: From Visit 1 (Day 1 - baseline) To Visit 3 (Day 29)
Acceptability Questionnaire assessment
Acceptability questionnaire regarding the use of the product completed by the subject/legal representative.
Time frame: Visit 1 (Day 1 - baseline), Visit 2 (Day8) and Visit 3 (Day 29)
Post-Inflammatory Hyper- or Hypo-pigmentation Intensity on a Target Lesion
Evolution of one selected post inflammatory hyperpigmentation area AND/OR one selected post inflammatory hypopigmentation area induced by atopic dermatitis assessed by the dermatologist using a 4-point lesion intensity scale (0=none to 3=severe).
Time frame: From Visit 1 (Day 1 - baseline) To Visit 3 (Day 29)
Extent of Dyschromic Areas
Evolution of the extent of skin areas affected by post-inflammatory dyschromia (hyper- or hypopigmentation) assessed by the investigator using the SCORAD parameter A methodology (rule of nines, scale 0 to 100), adapted to dyschromic lesions.
Time frame: From Visit 1 (Day 1 - baseline) To Visit 3 (Day 29)
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pierre Fabre Dermo Cosmetique →