Back to resultsAssessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Adapalene 0.1% and Benzoyl Peroxide 2.5% gel
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
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
Sites / Locations
- Thomas J. Stephens and Associates
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Adapalene 0.1% and Benzoyl Peroxide 2.5% gel
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01209949
Brief Title
Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris
Official Title
Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adapalene 0.1% and Benzoyl Peroxide 2.5% gel
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Adapalene 0.1% and Benzoyl Peroxide 2.5% gel
Other Intervention Name(s)
Epiduo® Gel
Intervention Description
Apply adapalene BPO gel once daily in the evening for 12 weeks
Primary Outcome Measure Information:
Title
Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12.
Description
Mean percent change from baseline in lesions counts (inflammatory, non-inflammatory, and total) at week 12.
Time Frame
Week 12
Title
Number of Participants With Tolerability Assessments Resulting in an Adverse Event
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald W Gottschalk, MD
Organizational Affiliation
Galderma R&D
Official's Role
Study Director
Facility Information:
Facility Name
Thomas J. Stephens and Associates
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75006
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris
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