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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01209949
• Other study ID #: US10179
• Status: Completed
• Phase: Phase 4
• Start date: October 2010
• Est. completion date: January 2011

Study information

• Verified date: January 2012
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Adapalene 0.1% and Benzoyl Peroxide 2.5% gel
Apply adapalene BPO gel once daily in the evening for 12 weeks

Locations

Country	Name	City	State
United States	Thomas J. Stephens and Associates	Carrollton	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12.	Mean percent change from baseline in lesions counts (inflammatory, non-inflammatory, and total) at week 12.	Week 12
Secondary	Number of Participants With Tolerability Assessments Resulting in an Adverse Event	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.	12 weeks