Comparative Efficacy and Safety of Benzoyl Peroxide Used in Combination With Clindamycin vs. Benzoyl Peroxide Used in Combination With Clindamycin and Doxycycline in the Treatment of Moderate Acne
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00837213 |
Recruitment Status :
Completed
First Posted : February 5, 2009
Results First Posted : August 31, 2010
Last Update Posted : May 25, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acne | Drug: Benzoyl peroxide with clindamycin Drug: Benzoyl peroxide with clindamycin and doxycycline | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 33 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | Comparative Efficacy and Safety of Benzoyl Peroxide Used in Combination With Clindamycin vs. Benzoyl Peroxide Used in Combination With Clindamycin and Doxycycline in the Treatment of Moderate Acne |
Study Start Date : | August 2007 |
Actual Primary Completion Date : | August 2008 |
Actual Study Completion Date : | August 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: BPO with clindamycin foam
Benzoyl peroxide (BPO) wash with clindamycin foam
|
Drug: Benzoyl peroxide with clindamycin
Benzoyl peroxide wash - Clindamycin foam
Other Name: Acne |
Active Comparator: BPO + clindamycin foam + doxycycline
Benzoyl peroxide (BPO) wash with clindamycin foam and doxycycline capsules
|
Drug: Benzoyl peroxide with clindamycin and doxycycline
Benzoyl peroxide wash - Clindamycin foam - Doxycycline capsules
Other Name: Acne |
- Percent Change in Inflammatory Acne Lesions From Baseline to Week 16 [ Time Frame: Baseline, Week 16 ]Percent change from baseline to week 16 in inflammatory acne lesions (pustules/papules)(chest and back)
- Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16. [ Time Frame: Baseline, Week 16 ]Percent change in Non-inflammatory acne lesions (whiteheads and blackheads)(chest and back) from baseline to week 16.
- Percent Change in Total Acne Lesion Counts From Baseline to Week 16 [ Time Frame: Baseline, Week 16 ]Percent change from baseline to week 16 in total acne lesions (inflammatory + non-inflammatory)
- Change in Investigator Global Assessment (IGA) [ Time Frame: Baseline, Weeks 4, 8,12, and 16 ]
Change in Investigator Global Assessment (IGA) Average values chest and back.
IGA scale:
0 - Clear
0.5 - Clear/almost clear
-
Almost Clear
1.5- Almost Clear/Mild
-
Mild
2.5- Mild/Moderate
- Moderate
3.5- Moderate/Severe
-
- Percent (%) Change in Inflammatory Lesion Counts (Chest and Back) From Baseline to Week 12 [ Time Frame: Baseline, Week 12 ]Percent change in inflammatory lesion counts (chest and back)from Baseline to Week 12
- Percent Change in Non-inflammatory Lesions (Chest and Back) From Baseline to Week 12 [ Time Frame: Baseline, Week 12 ]Percent change in non-inflammatory lesions (chest and back) from baseline to Week 12
- Percent Change in Total Lesions (Chest and Back) From Baseline to Week 12 [ Time Frame: Week 12 ]Percent change in total lesions (chest and back) from baseline to Week 12
- Percentage of Particpants With IGA Score at Week 16 [ Time Frame: Baseline, Week 16 ]
Investigator Global Assessment (IGA) at Week 16 based on the Investigator Global Assessment
IGA:
0 - Clear
0.5 - Clear/almost clear
-
Almost Clear
1.5- Almost Clear/Mild
-
Mild
2.5- Mild/Moderate
- Moderate
3.5- Moderate/Severe
-

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female subjects with acne vulgaris . Able to understand the requirements of the study and sign informed consent/HIPAA authorization forms.
Exclusion Criteria:
- Known hypersensitivity to any of the components of the study drugs or used of prohibited medications or any medical condition that contraindicate the subject's participation in the clinical study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00837213
United States, California | |
Center for Dermatology, Cosmetic and Laser Surgery | |
Fremont, California, United States, 94538 | |
United States, Nevada | |
Las Vegas Skin & Cancer Clinic | |
Las Vegas, Nevada, United States, 89129 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | Stiefel, a GSK Company |
ClinicalTrials.gov Identifier: | NCT00837213 |
Other Study ID Numbers: |
EVF0701 |
First Posted: | February 5, 2009 Key Record Dates |
Results First Posted: | August 31, 2010 |
Last Update Posted: | May 25, 2017 |
Last Verified: | May 2017 |
Acne |
Acne Vulgaris Acneiform Eruptions Skin Diseases Sebaceous Gland Diseases Doxycycline Clindamycin Clindamycin palmitate Clindamycin phosphate Benzoyl Peroxide |
Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Dermatologic Agents |