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

• 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

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2020-11-30
• Study Completion: 2021-03-31
• Status Verified: 2021-09
• Study First Submitted: 2021-09-08
• Study First Submitted QC: 2021-09-24
• Last Update Submitted: 2021-09-24
• Study First Posted: 2021-09-27
• Last Update Posted: 2021-09-27

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

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

Trial Locations

Locations (1)

Complife Italia S.r.l.; 🇮🇹 San Martino Siccomario, Italy