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Clinical Trials in India / NCT05575882
Recruiting Not applicable

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

NCT05575882 · tracked via the Priya Life Science India tracker
Sponsor
NAOS Argentina S.A.
Phase
Not applicable
Started
2022-11-03
Last updated
2025-03-25

Condition(s) studied

Atopic DermatitisEczema, Atopic

Investigational drug(s) / intervention(s)

Skin hydrationBarrier function measurementPotential of hydrogen measurement (pH)Clinical evaluation of atopic dermatitisQuality of life assessmentAssessment of the effect on itching and sleep disturbancesAssessment of the tolerance of the study product or placebo

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

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

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

Clinical evaluation of atopic dermatitis: EASI score on each visit. Non invasive technique.

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

Assessment of the effect on itching and sleep disturbances: Visual analogue scale from 0 to 10

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).

Study 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).

Eligibility

Sex
ALL
Min age
6 Months
Max age
15 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Cirec Latam Ciudad Autónoma de Buenos Aire Ciudad Autónoma de Buenos Aire Not Yet Recruiting
CIDP New Delhi India Recruiting
KK Women's & Children's Hospital Singapore Singapore Suspended
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05575882 on ClinicalTrials.gov ↗ ← All trials in India