Back to resultsAnti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream Intended for Very Dry, Irritated to Atopic Sensitive Skin.
Primary Purpose
Atopic Dermatitis, Eczema, Atopic
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Skin hydration
Barrier function measurement
Potential of hydrogen measurement (pH)
Clinical evaluation of atopic dermatitis
Quality of life assessment
Assessment of the effect on itching and sleep disturbances
Assessment of the tolerance of the study product or placebo
Sponsored by
About this trial
This is an interventional prevention trial for Atopic Dermatitis
Eligibility Criteria
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.
Sites / Locations
- Cirec LatamRecruiting
- KK Women's & Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Investigational product (BI 479 V1)
Placebo (BI 006)
Arm Description
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.
Same instructions of use as active comparator.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Tolerance of the study product or placebo
Collection of treatment-related adverse events during the study
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.
Change on the trans-epidermal water loss (TEWL).
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.
Change on the pH.
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.
Change on itching
Interview by dermatologist on each visit. Minimum value: 0; maximum value:10. Higher scores mean worse outcome.
Change on sleep disturbances.
Interview by dermatologist on each visit. Minimum value: 0; maximum value:10. Higher scores mean worse outcome.
Change on quality of life.
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.
Subjective appreciation of efficacy and acceptability by the parent(s)/legal representative(s) and/or their child.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05575882
Brief Title
Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream Intended for Very Dry, Irritated to Atopic Sensitive Skin.
Official Title
Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream Intended for Very Dry, Irritated to Atopic Sensitive Skin
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NAOS Argentina S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Eczema, Atopic
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicentric, double blind, randomized, comparative study with two parallel group: study group vs placebo group.
Masking
ParticipantCare ProviderInvestigator
Masking Description
white plastic bottles and automatized randomization in eCRF.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Investigational product (BI 479 V1)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo (BI 006)
Arm Type
Placebo Comparator
Arm Description
Same instructions of use as active comparator.
Intervention Type
Other
Intervention Name(s)
Skin hydration
Other Intervention Name(s)
Corneometer
Intervention Description
Skin hydration outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
Intervention Type
Other
Intervention Name(s)
Barrier function measurement
Other Intervention Name(s)
Transepidermal Water Loss (TEWL)
Intervention Description
TEWL measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
Intervention Type
Other
Intervention Name(s)
Potential of hydrogen measurement (pH)
Intervention Description
pH measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
Intervention Type
Other
Intervention Name(s)
Clinical evaluation of atopic dermatitis
Other Intervention Name(s)
Eczema Area and Severity Index (EASI)
Intervention Description
EASI score on each visit. Non invasive technique.
Intervention Type
Other
Intervention Name(s)
Quality of life assessment
Intervention Description
Cardiff questionnaires to assess quality of life of subjects and their family members.
Intervention Type
Other
Intervention Name(s)
Assessment of the effect on itching and sleep disturbances
Intervention Description
Visual analogue scale from 0 to 10
Intervention Type
Other
Intervention Name(s)
Assessment of the tolerance of the study product or placebo
Intervention Description
By collection of Adverse Events (AEs) on daily log and electronic Case Report Form (eCRF).
Primary Outcome Measure Information:
Title
Change of acute flares of eczema in patients with chronic atopic dermatitis (AD)
Description
Clinical evaluation by dermatologist on each visit and daily log statements by the parents.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Change of Atopic Dermatitis using the Eczema Area and Severity Index (EASI)
Description
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 treatment
Title
Change of Atopic Dermatitis using the Investigator's Global Assessment (IGA)
Description
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 treatment
Title
Tolerance of the study product or placebo
Description
Collection of treatment-related adverse events during the study
Time Frame
0-30, 31-60, 61-90 and 91-120 days of treatment
Title
Change of stratum corneum (SC) hydration.
Description
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 treatment
Title
Change on the trans-epidermal water loss (TEWL).
Description
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.
Time Frame
0-30, 31-60, 61-90 and 91-120 days of treatment
Title
Change on the pH.
Description
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.
Time Frame
0-30, 31-60, 61-90 and 91-120 days of treatment
Title
Change on itching
Description
Interview by dermatologist on each visit. Minimum value: 0; maximum value:10. Higher scores mean worse outcome.
Time Frame
0-30, 31-60, 61-90 and 91-120 days of treatment
Title
Change on sleep disturbances.
Description
Interview by dermatologist on each visit. Minimum value: 0; maximum value:10. Higher scores mean worse outcome.
Time Frame
0-30, 31-60, 61-90 and 91-120 days of treatment
Title
Change on quality of life.
Description
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.
Time Frame
0-30, 31-60, 61-90 and 91-120 days of treatment
Title
Subjective appreciation of efficacy and acceptability by the parent(s)/legal representative(s) and/or their child.
Description
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.
Time Frame
120 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Cirec Latam
City
Ciudad Autónoma de Buenos Aire
ZIP/Postal Code
1426
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shantal Valdés, PhD
Phone
005491123465946
Email
Shantal.Valdes@ar.naos.com
First Name & Middle Initial & Last Name & Degree
Alejandra Piegari, MD
Phone
005491164964851
Email
alepiegari@gmail.com
First Name & Middle Initial & Last Name & Degree
Margarita Larralde, Prof
First Name & Middle Initial & Last Name & Degree
Alejandra Piegari, MD
First Name & Middle Initial & Last Name & Degree
Marisa Zocca, MD
Facility Name
KK Women's & Children's Hospital
City
Singapore
ZIP/Postal Code
179939
Country
Singapore
Individual Site Status
Suspended
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25807867
Citation
Gayraud F, Sayag M, Jourdan E. Efficacy and tolerance assessment of a new type of dermocosmetic in infants and children with moderate atopic dermatitis. J Cosmet Dermatol. 2015 Jun;14(2):107-12. doi: 10.1111/jocd.12145. Epub 2015 Mar 23.
Results Reference
result
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Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream Intended for Very Dry, Irritated to Atopic Sensitive Skin.
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