Actively Recruiting
Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream for Very Dry, Irritated to Atopic Sensitive Skin.
Led by NAOS Argentina S.A. · Updated on 2025-03-25
100
Participants Needed
3
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream for Very Dry, Irritated to Atopic Sensitive Skin.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female between 6 months and 15 years old
- Moderate atopic dermatitis with an EASI score from 7.1 to 21 on the inclusion day
- Having on average one flare-up per month during the four months before the study, including the inclusion visit
- Presence of one atopic skin eruption at inclusion visit prescribed topical corticosteroids or calcineurin inhibitors
- Healthy except for atopic dermatitis and other atopic diseases such as allergic rhinitis, conjunctivitis, or asthma
- Able to maintain usual treatments like antihistamines, inhaled corticosteroids, or antileukotriene drugs during the study
- Written informed consent from parent(s)/legal representative(s) and children over 8 years (Argentina) or over 12 years (Singapore)
- Willing to continue normal hygiene and sunscreen use if applicable
- Willingness of participant and parent(s)/legal representative(s) to follow study protocol and procedures
You will not qualify if you...
- Presence of other skin conditions in the study area like acne or psoriasis
- Use of systemic treatments including oral steroids or immunosuppressants in the weeks before the study
- Use of skin-moisturizing products other than the study product or placebo from inclusion day
- Systemic therapy with immune-suppressive drugs or antibiotics within 14 days before study start
- Serious illness requiring regular systemic medication or conditions that could affect study evaluation
- Documented allergies to ingredients of the study product or placebo
- Participation in another clinical study during this study period
- Parent(s)/legal representative(s) considered unlikely to comply with the protocol by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Cirec Latam
Ciudad Autónoma de Buenos Aire, Ciudad Autónoma de Buenos Aire, Argentina, 1426
Not Yet Recruiting
2
CIDP
New Delhi, India, 110005
Actively Recruiting
3
KK Women's & Children's Hospital
Singapore, Singapore, Singapore, 179939
Suspended
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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