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

Official title

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

Overview

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).

Detailed description

This is a prospective, double blind, multicentric and comparative study including 5 visits (on D0 which corresponds to inclusion visit, D30, D60, D90, and D120). It will take place from June 2024 to June 2025 in Argentina (CIREC LATAM, Buenos Aires) and India (CIDP, New Dheli). This study will include 100 patients (50 in India and 50 in Argentina) who will be followed up for 120 days (± 3 days).

Interventions

• Other Skin hydration
  Skin hydration outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
• Other Barrier function measurement
  TEWL measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
• Other Potential of hydrogen measurement (pH)
  pH measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
• Other Clinical evaluation of atopic dermatitis
  EASI score on each visit. Non invasive technique.
• Other Quality of life assessment
  Cardiff questionnaires to assess quality of life of subjects and their family members.
• Other Assessment of the effect on itching and sleep disturbances
  Visual analogue scale from 0 to 10
• Other Assessment of the tolerance of the study product or placebo
  By collection of Adverse Events (AEs) on daily log and electronic Case Report Form (eCRF).

Primary outcome measures

• Change of acute flares of eczema in patients with chronic atopic dermatitis (AD) [Time frame: 4 months]

Secondary outcome measures (10)

• Change of Atopic Dermatitis using the Eczema Area and Severity Index (EASI) [Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment]
• Change of Atopic Dermatitis using the Investigator's Global Assessment (IGA) [Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment]
• Tolerance of the study product or placebo [Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment]
• Change of stratum corneum (SC) hydration. [Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment]
• Change on the trans-epidermal water loss (TEWL). [Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment]
• Change on the pH. [Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment]
• Change on itching [Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment]
• Change on sleep disturbances. [Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment]
• Change on quality of life. [Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment]
• Subjective appreciation of efficacy and acceptability by the parent(s)/legal representative(s) and/or their child. [Time frame: 120 days]

Eligibility criteria

Inclusion criteria

• 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:

Sex: male or female. Age: from 6 months to 15 years. Subject having on average one flare-up per month during the four months preceding the study, including the one observed on the inclusion visit D0. Subject having EASI value from 7.1 - 21 on D0 (moderate AD). Subject having one atopic eruption on the inclusion visit which the dermatologist will prescribe topical corticosteroids or calcineurin's inhibitors (pimecrolimus and/or tacrolimus).

Exclusion criteria

• Subject presenting cutaneous pathology in the studied zone other than AD (according to the investigator's appreciation, i.e., acne, psoriasis). Subject using systemic treatment, including oral steroids and oral immunosuppressants e.g., ciclosporin during the previous weeks liable to interfere with the assessment of the cutaneous tolerance of the study product or placebo (according to the investigator's appreciation). Subject using skin-moisturizing products from inclusion (D0) other than the study product or placebo. Subject who had systemic therapy with immune-suppressive drugs and antibiotics within the last 14 days before the beginning of the study Subject having serious illness that might require regular systemic medication (e.g., insulin-dependent diabetes, cancer) or conditions that exclude a participation or might influence the study evaluation. Subject with documented allergies to the study product or placebo ingredients. Subject enrolled in another clinical study during the study period. Parent(s)/legal representative(s) considered by the investigator to be likely not compliant to the protocol.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

Argentina · 1 center

• Cirec Latam — Ciudad Autónoma de Buenos Aire

India · 1 center

• CIDP — New Delhi

Singapore · 1 center

• KK Women's & Children's Hospital — Singapore

Publications

• 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

Identifiers

NCT: NCT05575882 · RC2022/PSagc/SG-AR

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗