Protocol Summary for 115576
| Protocol Id: | 115576 |
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| Title: | An Open-Label, 12-Week Study to Evaluate the Efficacy and Safety of the Acne System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%) in Subjects with Acne |
| Phase: | phase 4 |
| Acronym: | |
| FDA Regulated Intervention?: | No |
| Section 801 Clinical Trial?: | |
| Delayed Posting: | |
| IND/IDE Protocol?: | no |
| Study Type: | Interventional |
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| Brief Summary: | This study is being conducted to obtain safety, efficacy, and satisfaction data on the combination of topical Benzoyl Peroxide (BPO) 2.5% and the topical keratolytic agent Salicylic Acid (SA) 0.5% in the treatment of moderate to severe acne. Subjects with moderate or severe acne will be asked to apply the commercially available, over-the-counter products Foam Deep Cleanser (2.5% BPO), Foam Advanced Acne Treatment (2.5% BPO), and Foam Rejuvenating Toner (0.5% SA) daily for 12 weeks. No control group or reference treatment will be included. |
| Detailed Description: | This open-label, multicenter, study is being conducted to obtain safety, efficacy, and satisfaction data on an Acne System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%), which includes Foam Deep Cleanser (2.5% Benzoyl Peroxide) and Foam Advanced Acne Treatment (2.5% Benzoyl Peroxide) and Foam Rejuvenating Toner (0.5% Salicylic Acid), in the treatment of moderate to severe acne. Approximately 120 male or female subjects ages 12-35 years, inclusive, with moderate or severe acne as assessed by Investigator's Global Assessment (ISGA) and lesion counts are expected to be enrolled. Subjects will be instructed to use all 3 study products as part of a complete acne treatment system; no reference therapy or control group will be included. Subjects will be instructed to apply Foam Deep Cleanser (2.5% Benzoyl Peroxide) and Foam Advnced Acne Treatment (2.5% Benzoyl Peroxide) to the face each morning and Foam Deep Cleanser (2.5% Benzoyl Peroxide) and Foam Rejuvenating Toner (0.5% Salicylic Acid) each evening over an application period of 12 weeks. |
| Record Verification Date: | April 2012 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | June 2011 |
| Study Completion Date: | February 2012 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | January 2012 |
| Primary Completion Date Type: | Actual |
| Primary Purpose: | treatment |
| Allocation: | N\A |
| Masking: | Open Label |
| Masked Subject: | no |
| Masked Caregiver: | no |
| Masked Investigator: | no |
| Masked Assessor: | no |
| Study Design (Assignment): | Single Group Assignment |
| Study Classification (Endpoint): | Safety/Efficacy Study |
| Primary Outcomes: |
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| Eligibility Criteria: |
Click to view inclusion/exclusion criteria
Inclusion Criteria: |
| Gender: | Both |
| Minimum Age: | 12 Year |
| Maximum Age: | 35 Year |
| Enrollment: | 125 |
| Enrollment Type: | Actual |
| Healthy Volunteers?: | none |
| Central Contact: | Call Center |
| Central Contact Phone: | 877-379-3718 |
| Central Contact Email: | GSKClinicalSupportHD@gsk.com |
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| Overall Study Official: | GSK Clinical Trials |
| Overall Study Official Affiliation: | GlaxoSmithKline |
| Overall Study Official Role: | Study Director |
| Responsible Party Name/Official Title: | Cheri Hudson; Clinical Disclosure Advisor |
| Responsible Party Organization: | GSK Clinical Disclosure |
| Location and Contact Information: |
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Click to view inclusion/exclusion criteria