Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream for Very Dry, Irritated to Atopic Sensitive Skin.

NCT05575882 | Recruiting DMC

• 1 other identifier: RC2022/PSagc/SG-AR
• Study Type: interventional
• Target: 100
• Locations: 3 countries
• Sites: 3

Brief Summary

Multicentric, double blind, randomized, comparative study with two parallel group: study group vs placebo group. 5 visits: inclusion visit \[day (D) 0\] and 4 follow-up visits (D30, D60, D90, and D120).

Conditions

Atopic Dermatitis; Eczema, Atopic

Outcome Measures

Primary Outcomes (1)

• Change of acute flares of eczema in patients with chronic atopic dermatitis (AD)

  Clinical evaluation by dermatologist on each visit and daily log statements by the parents.

  4 months

Secondary Outcomes (10)

• Change of Atopic Dermatitis using the Eczema Area and Severity Index (EASI)

  0-30, 31-60, 61-90 and 91-120 days of treatment

• Change of Atopic Dermatitis using the Investigator's Global Assessment (IGA)

  0-30, 31-60, 61-90 and 91-120 days of treatment

• Tolerance of the study product or placebo

  0-30, 31-60, 61-90 and 91-120 days of treatment

• Change of stratum corneum (SC) hydration.

  0-30, 31-60, 61-90 and 91-120 days of treatment

• Change on the trans-epidermal water loss (TEWL).

  0-30, 31-60, 61-90 and 91-120 days of treatment

Study Arms (2)

Investigational product (BI 479 V1)

ACTIVE COMPARATOR

The study product or placebo will be applied twice daily on a clean and dry skin for 120 days. Follow "3-6-9 method" as follows: for babies (6 months to 24 months) use 3 pumps for the whole body (1 pump for face, 1 pump for trunk and arms and 1 pump for lower limbs), for children from 25 months: use 6 pumps for the whole body (1 pump for face, 3 pumps for trunk and arms and 2 pumps for lower limbs) and for children with height greater than 1.5 meters: use 9 pumps for the whole body (1 pump for face, 1 pump for chest, 1 pump for back, 1 pump per arm (x2) and 2 pumps per leg (x2). It will be applied from inclusion visit simultaneously with topical treatment in the following order: first the study product or placebo on the whole body followed by the topical treatment on the flare-up areas.

Other: Skin hydration; Other: Barrier function measurement; Other: Potential of hydrogen measurement (pH); Other: Clinical evaluation of atopic dermatitis; Other: Quality of life assessment; Other: Assessment of the effect on itching and sleep disturbances; Other: Assessment of the tolerance of the study product or placebo

Placebo (BI 006)

PLACEBO COMPARATOR

Same instructions of use as active comparator.

Other: Skin hydration; Other: Barrier function measurement; Other: Potential of hydrogen measurement (pH); Other: Clinical evaluation of atopic dermatitis; Other: Quality of life assessment; Other: Assessment of the effect on itching and sleep disturbances; Other: Assessment of the tolerance of the study product or placebo

Interventions

Skin hydration OTHER

Skin hydration outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.

Also known as: Corneometer

Investigational product (BI 479 V1); Placebo (BI 006)

Barrier function measurement OTHER

TEWL measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.

Also known as: Transepidermal Water Loss (TEWL)

Investigational product (BI 479 V1); Placebo (BI 006)

Potential of hydrogen measurement (pH) OTHER

pH measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.

Investigational product (BI 479 V1); Placebo (BI 006)

Clinical evaluation of atopic dermatitis OTHER

EASI score on each visit. Non invasive technique.

Also known as: Eczema Area and Severity Index (EASI)

Investigational product (BI 479 V1); Placebo (BI 006)

Quality of life assessment OTHER

Cardiff questionnaires to assess quality of life of subjects and their family members.

Investigational product (BI 479 V1); Placebo (BI 006)

Assessment of the effect on itching and sleep disturbances OTHER

Visual analogue scale from 0 to 10

Investigational product (BI 479 V1); Placebo (BI 006)

Assessment of the tolerance of the study product or placebo OTHER

By collection of Adverse Events (AEs) on daily log and electronic Case Report Form (eCRF).

Investigational product (BI 479 V1); Placebo (BI 006)

Eligibility Criteria

• Age: 6 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• General criteria:
• Healthy subject (except AD and other atopic diseases - allergic rhinitis, conjunctivitis, and asthma). The subject can keep its usual treatment (antihistamines, inhaled corticosteroids, and antileukotriene treatment) during the study if applicable. Written informed consent from the subject's parent(s)/legal representative(s) and children over 8 years old (specific Argentina) and over 12 years old (specific Singapore). Subject accepting to continue the normal conditions of hygiene and sunscreen (if applicable). Subject, parents/legal representative(s) willing to adhere to the study protocol and procedures.
• Specific criteria:

Sponsors & Collaborators

• NAOS Argentina S.A.: lead

Study Sites (3)

Cirec Latam

Ciudad Autónoma de Buenos Aire, Ciudad Autónoma de Buenos Aire, 1426, Argentina

NOT YET RECRUITING

CIDP

New Delhi, 110005, India

RECRUITING

KK Women's & Children's Hospital

Singapore, Singapore, 179939, Singapore

SUSPENDED

Related Publications (1)

• Gayraud F, Sayag M, Jourdan E. Efficacy and tolerance assessment of a new type of dermocosmetic in infants and children with moderate atopic dermatitis. J Cosmet Dermatol. 2015 Jun;14(2):107-12. doi: 10.1111/jocd.12145. Epub 2015 Mar 23.

  PMID: 25807867 BACKGROUND

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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: white plastic bottles and automatized randomization in eCRF.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicentric, double blind, randomized, comparative study with two parallel group: study group vs placebo group.

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 12, 2022
• Study Start: November 3, 2022
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1); AR (1); SG (1)