Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream Intended for Very Dry, Irritated to Atopic Sensitive Skin
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- NAOS Argentina S.A.
- Enrollment
- 100
- Locations
- 3
- Primary Endpoint
- Change of acute flares of eczema in patients with chronic atopic dermatitis (AD)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
white plastic bottles and automatized randomization in eCRF.
Eligibility Criteria
- Ages
- 6 Months to 15 Years (Child)
- Sex
- All
- Accepts 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 D
- •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.
Arms & Interventions
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.
Intervention: Skin hydration (Other)
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.
Intervention: Barrier function measurement (Other)
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.
Intervention: Potential of hydrogen measurement (pH) (Other)
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.
Intervention: Clinical evaluation of atopic dermatitis (Other)
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.
Intervention: Quality of life assessment (Other)
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.
Intervention: Assessment of the effect on itching and sleep disturbances (Other)
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.
Intervention: Assessment of the tolerance of the study product or placebo (Other)
Placebo (BI 006)
Same instructions of use as active comparator.
Intervention: Skin hydration (Other)
Placebo (BI 006)
Same instructions of use as active comparator.
Intervention: Barrier function measurement (Other)
Placebo (BI 006)
Same instructions of use as active comparator.
Intervention: Potential of hydrogen measurement (pH) (Other)
Placebo (BI 006)
Same instructions of use as active comparator.
Intervention: Clinical evaluation of atopic dermatitis (Other)
Placebo (BI 006)
Same instructions of use as active comparator.
Intervention: Quality of life assessment (Other)
Placebo (BI 006)
Same instructions of use as active comparator.
Intervention: Assessment of the effect on itching and sleep disturbances (Other)
Placebo (BI 006)
Same instructions of use as active comparator.
Intervention: Assessment of the tolerance of the study product or placebo (Other)
Outcomes
Primary Outcomes
Change of acute flares of eczema in patients with chronic atopic dermatitis (AD)
Time Frame: 4 months
Clinical evaluation by dermatologist on each visit and daily log statements by the parents.
Secondary Outcomes
- Tolerance of the study product or placebo(0-30, 31-60, 61-90 and 91-120 days of treatment)
- Change on itching(0-30, 31-60, 61-90 and 91-120 days of treatment)
- Change of Atopic Dermatitis using the Eczema Area and Severity Index (EASI)(0-30, 31-60, 61-90 and 91-120 days of treatment)
- Change of stratum corneum (SC) hydration.(0-30, 31-60, 61-90 and 91-120 days of treatment)
- Change on the trans-epidermal water loss (TEWL).(0-30, 31-60, 61-90 and 91-120 days of treatment)
- Change on the pH.(0-30, 31-60, 61-90 and 91-120 days of treatment)
- Change on quality of life.(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.(120 days)
- Change of Atopic Dermatitis using the Investigator's Global Assessment (IGA)(0-30, 31-60, 61-90 and 91-120 days of treatment)
- Change on sleep disturbances.(0-30, 31-60, 61-90 and 91-120 days of treatment)