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

Purpose

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.

Condition	Intervention	Phase
Acne Vulgaris	Drug: CTGel/ BPO Wash Drug: Soap Free Cleanser and CTGel	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 3, Multicenter, Assessor-Blinded Study Of The Tolerability Of a Topical Antibiotic and Retinoid Used In Conjunction With Benzoyl Peroxide Wash In Subjects With Mild-To-Moderate Facial Acne Vulgaris

Resource links provided by NLM:

MedlinePlus related topics: Acne Antibiotics

Drug Information available for: Benzoyl peroxide

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Local Tolerability - Skin Dryness [ Time Frame: Screening/baseline ] [ Designated as safety issue: No ]
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
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Local Tolerability - Skin Dryness [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
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
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Local Tolerability - Skin Dryness [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
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
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Local Tolerability - Skin Dryness [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
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
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Local Tolerability - Skin Scaling [ Time Frame: Screening/baseline ] [ Designated as safety issue: No ]
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
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Local Tolerability - Skin Scaling [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
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
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Local Tolerability - Skin Scaling [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
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
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Local Tolerability - Skin Scaling [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
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
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Local Tolerability - Erythema (Redness) [ Time Frame: Screening/baseline ] [ Designated as safety issue: No ]
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
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Local Tolerability - Erythema (Redness) [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
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
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Local Tolerability - Erythema (Redness) [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
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
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Local Tolerability - Erythema (Redness) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
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
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe

Secondary Outcome Measures:

Subject Assessment of Burning/Stinging [ Time Frame: Screening/baseline ] [ Designated as safety issue: No ]
Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:

0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Subject Assessment of Burning/Stinging [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:

0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Subject Assessment of Burning/Stinging [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:

0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Subject Assessment of Burning/Stinging [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:

0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Subject Assessment of Itching [ Time Frame: Screening/Baseline ] [ Designated as safety issue: No ]
Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:

0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Subject Assessment of Itching [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:

0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Subject Assessment of Itching [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:

0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe
Subject Assessment of Itching [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:

0 - None
1. - Trace
2. - Mild
3. - Moderate
4. - Marked
5. - Severe


Enrollment:	61
Study Start Date:	April 2009
Study Completion Date:	July 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	12 Years to 45 Years (Child, Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891982

Locations


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

Sponsors and Collaborators

Stiefel, a GSK Company

GlaxoSmithKline

Investigators


Study Director:	A GSK Clinical Trials	GlaxoSmithKline

More Information

Publications:

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.

Home PD, Kahn SE, Jones NP, Noronha D, Beck-Nielsen H, Viberti G; ADOPT Study Group; RECORD Steering Committee. Experience of malignancies with oral glucose-lowering drugs in the randomised controlled ADOPT (A Diabetes Outcome Progression Trial) and RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycaemia in Diabetes) clinical trials. Diabetologia. 2010 Sep;53(9):1838-45. doi: 10.1007/s00125-010-1804-y. Epub 2010 Jun 8.


Responsible Party:	Stiefel, a GSK Company
ClinicalTrials.gov Identifier:	NCT00891982 History of Changes
Other Study ID Numbers:	114679 W0265-306
Study First Received:	April 29, 2009
Results First Received:	October 6, 2010
Last Updated:	May 7, 2015
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:


Acne Vulgaris

Additional relevant MeSH terms:


Acne Vulgaris Acneiform Eruptions Skin Diseases Sebaceous Gland Diseases	Anti-Bacterial Agents Benzoyl Peroxide Anti-Infective Agents Dermatologic Agents

ClinicalTrials.gov processed this record on September 23, 2016