Clinical trial NCT05575882: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atopic Dermatitis
Eczema, Atopic
Lead sponsor: NAOS Argentina S.A.
Sponsor class: INDUSTRY
First posted: 2022-10-12
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentric, double blind, randomized, comparative study with two parallel group: study group vs placebo group.
Primary purpose: PREVENTION

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).

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).

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.

Primary outcomes:
measure: Change of acute flares of eczema in patients with chronic atopic dermatitis (AD)
timeFrame: 4 months
Secondary outcomes:
measure: Change of Atopic Dermatitis using the Eczema Area and Severity Index (EASI)
timeFrame: 0-30, 31-60, 61-90 and 91-120 days of treatment
measure: Change of Atopic Dermatitis using the Investigator's Global Assessment (IGA)
timeFrame: 0-30, 31-60, 61-90 and 91-120 days of treatment
measure: Tolerance of the study product or placebo
timeFrame: 0-30, 31-60, 61-90 and 91-120 days of treatment
measure: Change of stratum corneum (SC) hydration.
timeFrame: 0-30, 31-60, 61-90 and 91-120 days of treatment
measure: Change on the trans-epidermal water loss (TEWL).
timeFrame: 0-30, 31-60, 61-90 and 91-120 days of treatment
measure: Change on the pH.
timeFrame: 0-30, 31-60, 61-90 and 91-120 days of treatment
measure: Change on itching
timeFrame: 0-30, 31-60, 61-90 and 91-120 days of treatment
measure: Change on sleep disturbances.
timeFrame: 0-30, 31-60, 61-90 and 91-120 days of treatment
measure: Change on quality of life.
timeFrame: 0-30, 31-60, 61-90 and 91-120 days of treatment
measure: Subjective appreciation of efficacy and acceptability by the parent(s)/legal representative(s) and/or their child.
timeFrame: 120 days
Other outcomes:
Locations:
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Cirec Latam
city: New Delhi
country: India
facility: CIDP
city: Singapore
country: Singapore
facility: KK Women's & Children's Hospital
Study officials:
References:
citation: 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.