A Controlled Study to Evaluate the Efficacy and the Tolerability of a Cosmetic Active Ingredient Intended for Subjects With Atopic Dermatitis

Greenpharma S.A.S.

Status: Completed

Conditions: Mild to Moderate Atopic Dermatitis

Treatments: Other: Isopentenyltheophylline 0.44% + Glycerin 4.56%; Other: Glycerin 4.56%

Study type: Interventional

Funder types: Other

Identifiers

NCT05057351

H.E.HU.AD.NSO05.066.05.00

Details and patient eligibility

About

Evaluation of safety and clinical efficacy of an active ingredient versus placebo for the treatment of mild to moderate Atopic Dermatitis (AD) adults.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups, including a placebo group

Active ingredient

Experimental group

Description:

Isopentenyltheophylline 0.44% + Glycerin 4.56%

Treatment:

Other: Isopentenyltheophylline 0.44% + Glycerin 4.56%

Placebo

Placebo Comparator group

Description:

Glycerin 4.56%

Treatment:

Other: Glycerin 4.56%