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

• ClinicalTrials.gov Identifier: NCT01209949
• Recruitment Status: Completed
• First Posted: September 27, 2010
• Results First Posted: January 19, 2012
• Last Update Posted: August 1, 2022
• Sponsor: Galderma R&D
• Information provided by (Responsible Party): Galderma R&D

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acne Vulgaris	Drug: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris
• Study Start Date: October 2010
• Actual Primary Completion Date: January 2011
• Actual Study Completion Date: January 2011

Arms and Interventions

Arm	Intervention/treatment
Adapalene 0.1% and Benzoyl Peroxide 2.5% gel	Drug: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel; Apply adapalene BPO gel once daily in the evening for 12 weeks; Other Name: Epiduo® Gel

Outcome Measures

Primary Outcome Measures :

1. Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12 [ Time Frame: 12 weeks ]
   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.

Secondary Outcome Measures :

1. Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12. [ Time Frame: Week 12 ]
   Mean percent change from baseline in lesions counts (inflammatory, non-inflammatory, and total) at week 12.
2. Number of Participants With Tolerability Assessments Resulting in an Adverse Event [ Time Frame: 12 weeks ]
   Number of participants with tolerability assessments resulting in an adverse event. Tolerability assessments include erythema (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Scaling (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Dryness (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Stinging/Burning (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with a score of None being best and a score of Severe being worst.

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 25 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Texas

Thomas J. Stephens and Associates

Carrollton, Texas, United States, 75006

Sponsors and Collaborators

Galderma R&D

Investigators

• Study Director: Ronald W Gottschalk, MD; Galderma R&D

More Information

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT01209949
• Other Study ID Numbers: US10179
• First Posted: September 27, 2010
• Results First Posted: January 19, 2012
• Last Update Posted: August 1, 2022
• Last Verified: January 2012

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Adapalene; Benzoyl Peroxide; Dermatologic Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents