- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05575882
Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream Intended for Very Dry, Irritated to Atopic Sensitive Skin.
Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream Intended for Very Dry, Irritated to Atopic Sensitive Skin
Study Overview
Status
Conditions
Intervention / Treatment
- Other: Skin hydration
- Other: Barrier function measurement
- Other: Potential of hydrogen measurement (pH)
- Other: Clinical evaluation of atopic dermatitis
- Other: Quality of life assessment
- Other: Assessment of the effect on itching and sleep disturbances
- Other: Assessment of the tolerance of the study product or placebo
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ciudad Autónoma de Buenos Aire, Argentina, 1426
- Recruiting
- Cirec Latam
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Contact:
- Shantal Valdés, PhD
- Phone Number: 005491123465946
- Email: Shantal.Valdes@ar.naos.com
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Contact:
- Alejandra Piegari, MD
- Phone Number: 005491164964851
- Email: alepiegari@gmail.com
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Principal Investigator:
- Margarita Larralde, Prof
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Sub-Investigator:
- Alejandra Piegari, MD
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Sub-Investigator:
- Marisa Zocca, MD
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Singapore, Singapore, 179939
- Suspended
- KK Women's & Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
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Skin hydration outside flare-up areas on an initial dry skin (the same in each visit).
Non invasive technique.
Other Names:
TEWL measurement outside flare-up areas on an initial dry skin (the same in each visit).
Non invasive technique.
Other Names:
pH measurement outside flare-up areas on an initial dry skin (the same in each visit).
Non invasive technique.
EASI score on each visit.
Non invasive technique.
Other Names:
Cardiff questionnaires to assess quality of life of subjects and their family members.
Visual analogue scale from 0 to 10
By collection of Adverse Events (AEs) on daily log and electronic Case Report Form (eCRF).
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Placebo Comparator: Placebo (BI 006)
Same instructions of use as active comparator.
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Skin hydration outside flare-up areas on an initial dry skin (the same in each visit).
Non invasive technique.
Other Names:
TEWL measurement outside flare-up areas on an initial dry skin (the same in each visit).
Non invasive technique.
Other Names:
pH measurement outside flare-up areas on an initial dry skin (the same in each visit).
Non invasive technique.
EASI score on each visit.
Non invasive technique.
Other Names:
Cardiff questionnaires to assess quality of life of subjects and their family members.
Visual analogue scale from 0 to 10
By collection of Adverse Events (AEs) on daily log and electronic Case Report Form (eCRF).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of acute flares of eczema in patients with chronic atopic dermatitis (AD)
Time Frame: 4 months
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Clinical evaluation by dermatologist on each visit and daily log statements by the parents.
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4 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Atopic Dermatitis using the Eczema Area and Severity Index (EASI)
Time Frame: 0-30, 31-60, 61-90 and 91-120 days of treatment
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Clinical evaluation by dermatologist on each visit.
Minimum value: 0; maximum value:72.
Higher scores mean worse outcome.
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0-30, 31-60, 61-90 and 91-120 days of treatment
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Change of Atopic Dermatitis using the Investigator's Global Assessment (IGA)
Time Frame: 0-30, 31-60, 61-90 and 91-120 days of treatment
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Clinical evaluation by dermatologist on each visit.
Minimum value: 0; maximum value:4.
Higher scores mean worse outcome.
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0-30, 31-60, 61-90 and 91-120 days of treatment
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Tolerance of the study product or placebo
Time Frame: 0-30, 31-60, 61-90 and 91-120 days of treatment
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Collection of treatment-related adverse events during the study
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0-30, 31-60, 61-90 and 91-120 days of treatment
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Change of stratum corneum (SC) hydration.
Time Frame: 0-30, 31-60, 61-90 and 91-120 days of treatment
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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. |
0-30, 31-60, 61-90 and 91-120 days of treatment
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Change on the trans-epidermal water loss (TEWL).
Time Frame: 0-30, 31-60, 61-90 and 91-120 days of treatment
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Measurement performs with - Tewameter® TM Hex (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:20. Higher scores mean worse outcome. |
0-30, 31-60, 61-90 and 91-120 days of treatment
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Change on the pH.
Time Frame: 0-30, 31-60, 61-90 and 91-120 days of treatment
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Measurement perform with LAQUA pHmeter PHD72G. Subject 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:14. pH higher than 5,9 or lower than 4,5 scores mean worse outcome. |
0-30, 31-60, 61-90 and 91-120 days of treatment
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Change on itching
Time Frame: 0-30, 31-60, 61-90 and 91-120 days of treatment
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Interview by dermatologist on each visit.
Minimum value: 0; maximum value:10.
Higher scores mean worse outcome.
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0-30, 31-60, 61-90 and 91-120 days of treatment
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Change on sleep disturbances.
Time Frame: 0-30, 31-60, 61-90 and 91-120 days of treatment
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Interview by dermatologist on each visit.
Minimum value: 0; maximum value:10.
Higher scores mean worse outcome.
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0-30, 31-60, 61-90 and 91-120 days of treatment
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Change on quality of life.
Time Frame: 0-30, 31-60, 61-90 and 91-120 days of treatment
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Cardiff quality of life questionnaires fill in by subjects or parents according to age range.
The total score is calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
The questionnaires can also be expressed as a percentage of the maximum possible score of 30.
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0-30, 31-60, 61-90 and 91-120 days of treatment
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Subjective appreciation of efficacy and acceptability by the parent(s)/legal representative(s) and/or their child.
Time Frame: 120 days
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Questionnaire fill in by representative(s) and/or their child.
Score from "totally agree" to "totally disagree".
"Totally agree" and "agree" are considered positive answers (in percentage).
Somewhat agree and and totally disagree are considered negative answers (in percentage).
The questionnaires are expressed as a percentage.
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120 days
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC2022/PSagc/SG-AR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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