EFFICACY AND TOLERANCE OF AN EMOLLIENT CREAM IN SKIN OF COLOR

NCT07839897 | Completed

• 1 other identifier: RV4660B20240932
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Atopic Dermatitis (AD)

Keywords

Atopic Dermatitis; Cosmetic

Outcome Measures

Primary Outcomes (1)

• Atopic Dermatitis Severity by the investigator- SCORAD (SCORing Atopic Dermatitis)

  Evolution of the SCORAD assessed by the Investigator at each visit

  Visit 1 (Day 1 - baseline), Visit 2 (Day8) To Visit 3 (Day 29)

Secondary Outcomes (9)

• Atopic Dermatitis Severity by the investigator- L-SCORAD (Local SCORing Atopic Dermatitis)

  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)

  Visit 1 (Day 1 - baseline), Visit 2 (Day8) and Visit 3 (Day 29)

• Discomfort sensations

  Visit 1 (Day 1 - baseline), Visit 2 (Day8) and Visit 3 (Day 29)

• Dermatological tolerance of the tested product

  Visit 1 (Day 1 - baseline), Visit 2 (Day8) and Visit 3 (Day 29)

• Quality of life questionnaire

  From Visit 1 (Day 1 - baseline) To Visit 3 (Day 29)

Study Arms (1)

Emollient treatment group

EXPERIMENTAL

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

Interventions

Emollient cream RV4660B OTHER

Emollient cream, applied once daily to face and body for a period of 4 weeks.

Emollient treatment group

Eligibility Criteria

• Age: 2 Months - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female (no minimum required);
• Age as presented below:
• years old (n=20)
• years old (n=15)
• days to 23 months (n=15)
• Phototypes IV-VI according to the Fitzpatrick scale following the distribution bellow:
• Phototype IV: at least 2 by each age group
• Phototypes V and VI: at least 75% by each age group and at least 2 by phototype
• Subjects presenting atopic dermatitis according to the definition of "the U.K Working Party's Diagnostic Criteria for Atopic Dermatitis";
• Presenting atopic dermatitis with a SCORAD from 15 to 30
• Subjects (18-45 years old) presenting at least one PIH and/or post inflammatory hypopigmentation induced by atopic dermatitis

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Bárbara NAHUM

Rio de Janeiro, Rio de Janeiro, 20070-900, Brazil

Location

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: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 24, 2026
• Study Start: May 7, 2025
• Primary Completion: August 21, 2025
• Study Completion: August 21, 2025
• Last Updated: September 24, 2026

Record last verified: 2026-09

Locations

BR (1)