Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris

Galderma

Status and phase

Completed

Phase 4

Conditions

Acne Vulgaris

Treatments

Drug: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT01209949

US10179

Details and patient eligibility

About

The purpose of this study is to assess subjects' experiences using Adapalene BPO gel to treat mild to moderate acne vulgaris using efficacy measurements, quality of life instruments, and video diaries.

Enrollment

30 patients

Sex

All

Ages

16 to 25 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female subjects, aged 16 to 25 years inclusive;
Subjects with mild or moderate facial acne (Investigator's Global Assessment (IGA) = 2 or 3;
A minimum of 10 inflammatory lesions (papules and pustules) on the face (excluding the nose);
Subjects who agree to be photographed at each visit;
Subjects who agree to be video recorded by study designated staff members. They should be able to clearly and comfortably communicate their responses to questions and express their thoughts related to their disease and treatment throughout the study

Exclusion criteria

Subjects with nodules, cysts, acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.) or severe acne requiring systemic treatment;
Subjects with a wash-out period for topical acne treatment on the face less than 30 days
Subjects with a wash-out period for systemic acne treatment less than 30 days with the exception of isotretinoin which requires a washout of 4 months;
Subjects who are currently being treated with antibiotics;
Subjects who foresee intensive ultraviolet (UV) exposure during the study (mountain sports, UV radiation, sunbathing, tanning beds, etc.);
Subjects who refuse photographic and videography procedures and/or refuse to sign a full release for their use in promotional materials