NCT05057351CompletedNot Applicable
Randomized, Double Blind, Clinical Study for Evaluating the Efficacy and the Tolerability of a Cosmetic Active Ingredient Intended for Subjects With Atopic Dermatitis. Controlled Study vs Placebo
Greenpharma S.A.S.2 sites in 1 country44 target enrollmentStarted: September 1, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- Change in severity of Atopic Dermatitis as assessed using the SCORing Atopic Dermatitis (SCORAD)
Study Overview
Brief Summary
Evaluation of safety and clinical efficacy of an active ingredient versus placebo for the treatment of mild to moderate Atopic Dermatitis (AD) adults.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Main Inclusion Criteria:
- •Good general health
- •Phototype I to IV
- •Mild to moderate SCORAD (between 15 and 25)
Exclusion Criteria
- •Pregnant/breastfeeding female or who have planned a pregnancy during the study period
- •Positive history for atopy or hypersensitive skin
- •Subjects under systemically pharmacological treatment
- •Subjects under locally pharmacological treatment on the skin area monitored during the test
- •Subjects with congenital or acquired immunodeficiency
- •Subjects under treatment with food supplements which could interfere with the functionality of the product under study
- •Subjects which show other skin alterations on the monitored area except for acne lesions
- •Subjects with known or suspected sensitization to one or more test formulation ingredients
Outcomes
Primary Outcomes
Change in severity of Atopic Dermatitis as assessed using the SCORing Atopic Dermatitis (SCORAD)
Time Frame: 7, 14 and 28 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
Loading locations...
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