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

NCT ID: NCT01209949

Last Updated: 2022-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-01-31

Brief Summary

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adapalene 0.1% and Benzoyl Peroxide 2.5% gel

Group Type: OTHER

Adapalene 0.1% and Benzoyl Peroxide 2.5% gel

Intervention Type: DRUG

Apply adapalene BPO gel once daily in the evening for 12 weeks

Interventions

Adapalene 0.1% and Benzoyl Peroxide 2.5% gel

Apply adapalene BPO gel once daily in the evening for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Epiduo® Gel

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald W Gottschalk, MD

Role: STUDY_DIRECTOR

Galderma R&D

Locations

Thomas J. Stephens and Associates

Carrollton, Texas, United States

Countries

United States

Other Identifiers

US10179

Identifier Type: -

Identifier Source: org_study_id