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

NCT01209949 | Completed Phase 4 Results

• 1 other identifier: US10179
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12

  Number of participants who were a Success (Subject's Global Assessment of 'Clear or 'Almost Clear') at week 12. Subject's Global Assessment is measured on a scale (Clear, Almost Clear, Mild, Moderate, Severe, Very Severe) with Clear being best and Very Severe being worst.

  12 weeks

Secondary Outcomes (2)

• Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12.

  Week 12

• Number of Participants With Tolerability Assessments Resulting in an Adverse Event

  12 weeks

Study Arms (1)

Adapalene 0.1% and Benzoyl Peroxide 2.5% gel

OTHER

Drug: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel

Interventions

Adapalene 0.1% and Benzoyl Peroxide 2.5% gel DRUG

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

Also known as: Epiduo® Gel

Adapalene 0.1% and Benzoyl Peroxide 2.5% gel

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Thomas J. Stephens and Associates

Carrollton, Texas, 75006, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene; Benzoyl Peroxide; Gels

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Norman Preston
• Organization: Galderma Laboratories, L.P.

Norman.Preston@galderma.com

817-961-5360

Study Officials

• Ronald W Gottschalk, MD

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2010
• First Posted: September 27, 2010
• Study Start: October 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: August 1, 2022
• Results First Posted: January 19, 2012

Record last verified: 2012-01

Locations

US (1)