Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream for Very Dry, Irritated to Atopic Sensitive Skin.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-15
SponsorNAOS Argentina S.A.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Skin hydration
Other interventionSkin hydration outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
Barrier function measurement
Other interventionTEWL measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
Potential of hydrogen measurement (pH)
Other interventionpH measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
Clinical evaluation of atopic dermatitis
Other interventionEASI score on each visit. Non invasive technique.
Quality of life assessment
Other interventionCardiff questionnaires to assess quality of life of subjects and their family members.
Assessment of the effect on itching and sleep disturbances
Other interventionVisual analogue scale from 0 to 10
Assessment of the tolerance of the study product or placebo
Other interventionBy collection of Adverse Events (AEs) on daily log and electronic Case Report Form (eCRF).
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Investigational product (BI 479 V1)Active comparator 7 interventions
Group B: Placebo (BI 006)Placebo comparator 7 interventions
Trial outcomes
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.
Time frame
4 monthsSecondary outcomes
1
Change of Atopic Dermatitis using the Eczema Area and Severity Index (EASI)
Clinical evaluation by dermatologist on each visit. Minimum value: 0; maximum value:72. Higher scores mean worse outcome.
Time frame
0-30, 31-60, 61-90 and 91-120 days of treatment2
Change of Atopic Dermatitis using the Investigator's Global Assessment (IGA)
Clinical evaluation by dermatologist on each visit. Minimum value: 0; maximum value:4. Higher scores mean worse outcome.
Time frame
0-30, 31-60, 61-90 and 91-120 days of treatment3
Tolerance of the study product or placebo
Collection of treatment-related adverse events during the study
Time frame
0-30, 31-60, 61-90 and 91-120 days of treatment4
Change of stratum corneum (SC) hydration.
Measurement performed with -Corneometer® CM825 (Courage + Khazaka) and MPACT + software (Monaderm). Subjects must not have applied anything to the forearms on the morning of the measurements. Subject acclimatize for at least 15 minutes in the lab under standardised conditions, with bare test area: - room temperature: 20-22°C; \- relative humidity: 40-60%. Dry skin area (the same in all visits): the most recommended area are the forearms (avoid flare-up areas). Minimum value: 0; maximum value:60. Higher scores mean better outcome.
Time frame
0-30, 31-60, 61-90 and 91-120 days of treatmentSponsors and contacts
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Source ClinicalTrials.gov