A Clinical Study to Evaluate the Tolerability of a Topical Antibiotic and Retinoid Used in a Combined Regimen With a BPO Wash
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ClinicalTrials.gov Identifier: NCT00891982 |
Recruitment Status
:
Completed
First Posted
: May 1, 2009
Results First Posted
: July 25, 2011
Last Update Posted
: May 24, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acne Vulgaris | Drug: CTGel/ BPO Wash Drug: Soap Free Cleanser and CTGel | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3B, Multicenter, Assessor-Blinded Study of the Tolerability of Clindamycin 1%-Tretinoin 0.025% Gel Used in Conjunction With Benzoyl Peroxide 4% Wash in Subjects With Mild to Moderate Facial Acne Vulgaris |
Actual Study Start Date : | April 1, 2009 |
Actual Primary Completion Date : | June 1, 2009 |
Actual Study Completion Date : | June 5, 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: CTGel plus BPO wash
Benzoyl peroxide (BPO) Wash in the morning and CTGel in the evening
|
Drug: CTGel/ BPO Wash
Benzoyl Peroxide (BPO) wash will be used once daily in the morning for 28 days Clindamycin and Tretinoin (CT) gel will be used once daily in the evening for 28 days. Other Name: Veltin
|
Active Comparator: CTGel
Soap Free Cleanser in the morning and CTGel in the evening
|
Drug: Soap Free Cleanser and CTGel
Soap Free Cleanser will be used once daily in the morning for 28 days Clindamycin and Tretinoin gel will be used once daily in the evening for 28 days. Other Name: Veltin
|
- Local Tolerability - Skin Dryness [ Time Frame: Screening/baseline ]
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
- - Trace
- - Mild
- - Moderate
- - Marked
- - Severe
- Local Tolerability - Skin Dryness [ Time Frame: Week 1 ]
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
- - Trace
- - Mild
- - Moderate
- - Marked
- - Severe
- Local Tolerability - Skin Dryness [ Time Frame: Week 2 ]
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
- - Trace
- - Mild
- - Moderate
- - Marked
- - Severe
- Local Tolerability - Skin Dryness [ Time Frame: Week 4 ]
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
- - Trace
- - Mild
- - Moderate
- - Marked
- - Severe
- Local Tolerability - Skin Scaling [ Time Frame: Screening/baseline ]
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
- - Trace
- - Mild
- - Moderate
- - Marked
- - Severe
- Local Tolerability - Skin Scaling [ Time Frame: Week 1 ]
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
- - Trace
- - Mild
- - Moderate
- - Marked
- - Severe
- Local Tolerability - Skin Scaling [ Time Frame: Week 2 ]
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
- - Trace
- - Mild
- - Moderate
- - Marked
- - Severe
- Local Tolerability - Skin Scaling [ Time Frame: Week 4 ]
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
- - Trace
- - Mild
- - Moderate
- - Marked
- - Severe
- Local Tolerability - Erythema (Redness) [ Time Frame: Screening/baseline ]
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
- - Trace
- - Mild
- - Moderate
- - Marked
- - Severe
- Local Tolerability - Erythema (Redness) [ Time Frame: Week 1 ]
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
- - Trace
- - Mild
- - Moderate
- - Marked
- - Severe
- Local Tolerability - Erythema (Redness) [ Time Frame: Week 2 ]
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
- - Trace
- - Mild
- - Moderate
- - Marked
- - Severe
- Local Tolerability - Erythema (Redness) [ Time Frame: Week 4 ]
Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:
0 - None
- - Trace
- - Mild
- - Moderate
- - Marked
- - Severe
- Subject Assessment of Burning/Stinging [ Time Frame: Screening/baseline ]
Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:
0 - None
- - Trace
- - Mild
- - Moderate
- - Marked
- - Severe
- Subject Assessment of Burning/Stinging [ Time Frame: Week 1 ]
Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:
0 - None
- - Trace
- - Mild
- - Moderate
- - Marked
- - Severe
- Subject Assessment of Burning/Stinging [ Time Frame: Week 2 ]
Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:
0 - None
- - Trace
- - Mild
- - Moderate
- - Marked
- - Severe
- Subject Assessment of Burning/Stinging [ Time Frame: Week 4 ]
Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:
0 - None
- - Trace
- - Mild
- - Moderate
- - Marked
- - Severe
- Subject Assessment of Itching [ Time Frame: Screening/Baseline ]
Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:
0 - None
- - Trace
- - Mild
- - Moderate
- - Marked
- - Severe
- Subject Assessment of Itching [ Time Frame: Week 1 ]
Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:
0 - None
- - Trace
- - Mild
- - Moderate
- - Marked
- - Severe
- Subject Assessment of Itching [ Time Frame: Week 2 ]
Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:
0 - None
- - Trace
- - Mild
- - Moderate
- - Marked
- - Severe
- Subject Assessment of Itching [ Time Frame: Week 4 ]
Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:
0 - None
- - Trace
- - Mild
- - Moderate
- - Marked
- - 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: | 12 Years to 45 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects with mild to moderate facial acne vulgaris, with no history of known or suspected hypersensitivity or previous allergic reaction to any of the ingredients of the study products (eg, topical antibiotics, retinoids or benzoyl peroxide), capable of understanding and willing to provide signed and dated written voluntary informed consent and able to complete the study and to comply with study instructions.
- Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.
Exclusion Criteria:
- Use of topical antibiotics on the face within the past 2 weeks or use of systemic antibiotics within the past 4 weeks.

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): NCT00891982
United States, Florida | |
Dermatology Associates Research | |
Coral Gables, Florida, United States, 33134 | |
United States, Michigan | |
Grekin Skin Institute | |
Warren, Michigan, United States, 48088 | |
United States, North Carolina | |
Dermatology Consulting Services | |
High Point, North Carolina, United States, 27262 | |
United States, Tennessee | |
The Skin Wellness Center, PC | |
Knoxville, Tennessee, United States, 37922 | |
United States, Washington | |
Premier Clinical Research | |
Spokane, Washington, United States, 99204 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Publications:
Responsible Party: | Stiefel, a GSK Company |
ClinicalTrials.gov Identifier: | NCT00891982 History of Changes |
Other Study ID Numbers: |
114679 |
First Posted: | May 1, 2009 Key Record Dates |
Results First Posted: | July 25, 2011 |
Last Update Posted: | May 24, 2017 |
Last Verified: | May 2017 |
Keywords provided by GlaxoSmithKline ( Stiefel, a GSK Company ):
Acne Vulgaris |
Additional relevant MeSH terms:
Acne Vulgaris Acneiform Eruptions Skin Diseases Sebaceous Gland Diseases Clindamycin Clindamycin palmitate Clindamycin phosphate Clindamycin, tretinoin drug combination Benzoyl Peroxide |
Tretinoin Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Dermatologic Agents Antineoplastic Agents Keratolytic Agents |