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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CTGel/ BPO Wash
Soap Free Cleanser and CTGel
Sponsored by
Stiefel, a GSK Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne Vulgaris

Eligibility Criteria

12 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dermatology Associates Research
  • Grekin Skin Institute
  • Dermatology Consulting Services
  • The Skin Wellness Center, PC
  • Premier Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CTGel plus BPO wash

CTGel

Arm Description

Benzoyl peroxide (BPO) Wash in the morning and CTGel in the evening

Soap Free Cleanser in the morning and CTGel in the evening

Outcomes

Primary Outcome Measures

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
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
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
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
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
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
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
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
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
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
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
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

Secondary Outcome Measures

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
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
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
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
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
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
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
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

Full Information

First Posted
April 29, 2009
Last Updated
May 19, 2017
Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00891982
Brief Title
A Clinical Study to Evaluate the Tolerability of a Topical Antibiotic and Retinoid Used in a Combined Regimen With a BPO Wash
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 1, 2009 (Actual)
Primary Completion Date
June 1, 2009 (Actual)
Study Completion Date
June 5, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CTGel plus BPO wash
Arm Type
Experimental
Arm Description
Benzoyl peroxide (BPO) Wash in the morning and CTGel in the evening
Arm Title
CTGel
Arm Type
Active Comparator
Arm Description
Soap Free Cleanser in the morning and CTGel in the evening
Intervention Type
Drug
Intervention Name(s)
CTGel/ BPO Wash
Other Intervention Name(s)
Veltin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Soap Free Cleanser and CTGel
Other Intervention Name(s)
Veltin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Local Tolerability - Skin Dryness
Description
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
Time Frame
Screening/baseline
Title
Local Tolerability - Skin Dryness
Description
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
Time Frame
Week 1
Title
Local Tolerability - Skin Dryness
Description
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
Time Frame
Week 2
Title
Local Tolerability - Skin Dryness
Description
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
Time Frame
Week 4
Title
Local Tolerability - Skin Scaling
Description
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
Time Frame
Screening/baseline
Title
Local Tolerability - Skin Scaling
Description
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
Time Frame
Week 1
Title
Local Tolerability - Skin Scaling
Description
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
Time Frame
Week 2
Title
Local Tolerability - Skin Scaling
Description
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
Time Frame
Week 4
Title
Local Tolerability - Erythema (Redness)
Description
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
Time Frame
Screening/baseline
Title
Local Tolerability - Erythema (Redness)
Description
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
Time Frame
Week 1
Title
Local Tolerability - Erythema (Redness)
Description
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
Time Frame
Week 2
Title
Local Tolerability - Erythema (Redness)
Description
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
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Subject Assessment of Burning/Stinging
Description
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
Time Frame
Screening/baseline
Title
Subject Assessment of Burning/Stinging
Description
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
Time Frame
Week 1
Title
Subject Assessment of Burning/Stinging
Description
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
Time Frame
Week 2
Title
Subject Assessment of Burning/Stinging
Description
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
Time Frame
Week 4
Title
Subject Assessment of Itching
Description
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
Time Frame
Screening/Baseline
Title
Subject Assessment of Itching
Description
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
Time Frame
Week 1
Title
Subject Assessment of Itching
Description
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
Time Frame
Week 2
Title
Subject Assessment of Itching
Description
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
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
Dermatology Associates Research
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Grekin Skin Institute
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Dermatology Consulting Services
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
The Skin Wellness Center, PC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21284283
Citation
Draelos ZD, Potts A, Alio 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.
Results Reference
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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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