A Controlled Study to Evaluate the Efficacy and the Tolerability of a Cosmetic Active Ingredient Intended for Subjects With Atopic Dermatitis
Not Applicable
Completed
- Conditions
- Mild to Moderate Atopic Dermatitis
- Interventions
- Other: Glycerin 4.56%Other: Isopentenyltheophylline 0.44% + Glycerin 4.56%
- Registration Number
- NCT05057351
- Lead Sponsor
- Greenpharma S.A.S.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
- Good general health
- Phototype I to IV
- Mild to moderate SCORAD (between 15 and 25)
Main
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Glycerin 4.56% Glycerin 4.56% Active ingredient Isopentenyltheophylline 0.44% + Glycerin 4.56% Isopentenyltheophylline 0.44% + Glycerin 4.56%
- Primary Outcome Measures
Name Time Method Change in severity of Atopic Dermatitis as assessed using the SCORing Atopic Dermatitis (SCORAD) 7, 14 and 28 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Complife Italia S.r.l.
🇮🇹San Martino Siccomario, Italy