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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
100
Skin hydration outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
TEWL measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
pH measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
Cirec Latam
Ciudad Autónoma de Buenos Aire, Ciudad Autónoma de Buenos Aire, Argentina
NOT_YET_RECRUITINGCIDP
New Delhi, India
RECRUITINGKK Women's & Children's Hospital
Singapore, Singapore, Singapore
SUSPENDEDChange 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 months
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 treatment
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 treatment
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 treatment
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 treatment
Change on the trans-epidermal water loss (TEWL).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
EASI score on each visit. Non invasive technique.
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).
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
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.
Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment
Change on itching
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
Change on sleep disturbances.
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
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.
Time frame: 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.
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