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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-03

Study Completion Date

2025-11-30

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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Atopic Dermatitis Eczema, Atopic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

white plastic bottles and automatized randomization in eCRF.

Study Groups

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Investigational product (BI 479 V1)

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.

Group Type ACTIVE_COMPARATOR

Skin hydration

Intervention Type OTHER

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

Barrier function measurement

Intervention Type OTHER

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

Potential of hydrogen measurement (pH)

Intervention Type OTHER

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

Clinical evaluation of atopic dermatitis

Intervention Type OTHER

EASI score on each visit. Non invasive technique.

Quality of life assessment

Intervention Type OTHER

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

Assessment of the effect on itching and sleep disturbances

Intervention Type OTHER

Visual analogue scale from 0 to 10

Assessment of the tolerance of the study product or placebo

Intervention Type OTHER

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

Placebo (BI 006)

Same instructions of use as active comparator.

Group Type PLACEBO_COMPARATOR

Skin hydration

Intervention Type OTHER

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

Barrier function measurement

Intervention Type OTHER

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

Potential of hydrogen measurement (pH)

Intervention Type OTHER

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

Clinical evaluation of atopic dermatitis

Intervention Type OTHER

EASI score on each visit. Non invasive technique.

Quality of life assessment

Intervention Type OTHER

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

Assessment of the effect on itching and sleep disturbances

Intervention Type OTHER

Visual analogue scale from 0 to 10

Assessment of the tolerance of the study product or placebo

Intervention Type OTHER

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

Interventions

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Skin hydration

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

Intervention Type OTHER

Barrier function measurement

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

Intervention Type 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.

Intervention Type OTHER

Clinical evaluation of atopic dermatitis

EASI score on each visit. Non invasive technique.

Intervention Type OTHER

Quality of life assessment

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

Intervention Type OTHER

Assessment of the effect on itching and sleep disturbances

Visual analogue scale from 0 to 10

Intervention Type 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).

Intervention Type OTHER

Other Intervention Names

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Corneometer Transepidermal Water Loss (TEWL) Eczema Area and Severity Index (EASI)

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No