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NCT00891982 Clinical Trial

A Clinical Study to Evaluate the Tolerability of a Topical Antibiotic and Retinoid Used in a Combined Regimen With a BPO Wash

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00891982
Other study ID # 114679
Secondary ID
Status Completed
Phase Phase 3
First received April 29, 2009
Last updated May 19, 2017
Start date April 1, 2009
Est. completion date June 5, 2009

Study information
Verified date May 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the tolerability of a combined regimen of a topical antibiotic and retinoid and a benzoyl peroxide wash.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date June 5, 2009
Est. primary completion date June 1, 2009
Accepts healthy volunteers No
Gender All
Age group 12 Years to 45 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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.
• 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.

Locations
Country Name City State
United States Dermatology Associates Research Coral Gables Florida
United States Dermatology Consulting Services High Point North Carolina
United States The Skin Wellness Center, PC Knoxville Tennessee
United States Premier Clinical Research Spokane Washington
United States Grekin Skin Institute Warren Michigan

Sponsors (2)
Lead Sponsor Collaborator
Stiefel, a GSK Company GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Draelos ZD, Potts A, Alió Saenz AB; W0265-306 Study Group.. Randomized tolerability analysis of clindamycin phosphate 1.2%-tretinoin 0.025% gel used with benzoyl peroxide wash 4% for acne vulgaris. Cutis. 2010 Dec;86(6):310-8. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Local Tolerability - Skin Dryness 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		 Screening/baseline
Primary Local Tolerability - Skin Dryness 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		 Week 1
Primary Local Tolerability - Skin Dryness 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		 Week 2
Primary Local Tolerability - Skin Dryness 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		 Week 4
Primary Local Tolerability - Skin Scaling 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		 Screening/baseline
Primary Local Tolerability - Skin Scaling 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		 Week 1
Primary Local Tolerability - Skin Scaling 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		 Week 2
Primary Local Tolerability - Skin Scaling 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		 Week 4
Primary Local Tolerability - Erythema (Redness) 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		 Screening/baseline
Primary Local Tolerability - Erythema (Redness) 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		 Week 1
Primary Local Tolerability - Erythema (Redness) 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		 Week 2
Primary Local Tolerability - Erythema (Redness) 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		 Week 4
Secondary Subject Assessment of Burning/Stinging 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		 Screening/baseline
Secondary Subject Assessment of Burning/Stinging 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		 Week 1
Secondary Subject Assessment of Burning/Stinging 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		 Week 2
Secondary Subject Assessment of Burning/Stinging 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		 Week 4
Secondary Subject Assessment of Itching 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		 Screening/Baseline
Secondary Subject Assessment of Itching 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		 Week 1
Secondary Subject Assessment of Itching 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		 Week 2
Secondary Subject Assessment of Itching 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		 Week 4
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