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OpenTrials
Completed

NCT Number: NCT07839897

EFFICACY AND TOLERANCE OF AN EMOLLIENT CREAM IN SKIN OF COLOR

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)

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Key information

Conditions

Atopic Dermatitis (AD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 month–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bárbara NAHUM

Rio de Janeiro, 20070-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female (no minimum required);
  • Age as presented below:
  • 18-45 years old (n=20)
  • 2-17 years old (n=15)
  • 28 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
  • Subjects who used the same cleansing product on face and body, the same make-up (if applicable), the same sunscreen product for at least two weeks before inclusion and remain stable during the whole study

Treatment and study plan

Emollient cream RV4660B

Other

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

Primary outcomes

  1. Atopic Dermatitis Severity by the investigator- SCORAD (SCORing Atopic Dermatitis)

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

    Evolution of the SCORAD assessed by the Investigator at each visit

Secondary outcomes

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

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

    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)

  2. Atopic Dermatitis Severity by the subject- PO-SCORAD (Patient-Oriented SCORing Atopic Dermatitis)

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

    Evolution of the PO-SCORAD self-assessed by the subject or parent's)/legal representative at each visit

  3. Discomfort sensations

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

    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)

  4. Dermatological tolerance of the tested product

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

    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)

  5. Quality of life questionnaire

    Time frame: From Visit 1 (Day 1 - baseline) To Visit 3 (Day 29)

    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

  6. Atopic dermatitis disease control

    Time frame: From Visit 1 (Day 1 - baseline) To Visit 3 (Day 29)

    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.

  7. Acceptability Questionnaire assessment

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

    Acceptability questionnaire regarding the use of the product completed by the subject/legal representative.

  8. Post-Inflammatory Hyper- or Hypo-pigmentation Intensity on a Target Lesion

    Time frame: From Visit 1 (Day 1 - baseline) To Visit 3 (Day 29)

    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).

  9. Extent of Dyschromic Areas

    Time frame: From Visit 1 (Day 1 - baseline) To Visit 3 (Day 29)

    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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Pierre Fabre Dermo Cosmetique

Industry

Registry information

Official study title

EVALUATION OF THE EFFICACY AND TOLERANCE OF A FACE AND BODY EMOLLIENT CREAM IN SUBJECTS (INFANTS, CHILDREN, ADULTS) WITH MILD TO MODERATE ATOPIC DERMATITIS UNDER DERMATOLOGICAL CONTROL

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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