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

May 19, 2017 updated by: Stiefel, a GSK Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Dermatology Associates Research
    • Michigan
      • Warren, Michigan, United States, 48088
        • Grekin Skin Institute
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Dermatology Consulting Services
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
        • The Skin Wellness Center, PC
    • Washington
      • Spokane, Washington, United States, 99204
        • Premier Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Veltin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Screening/baseline
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

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Week 1
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

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Week 2
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

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Week 4
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

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Screening/baseline
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

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Week 1
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

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Week 2
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

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Week 4
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

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Screening/baseline
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

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Week 1
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

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Week 2
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

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Screening/baseline
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

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Week 1
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

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Week 2
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

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Week 4
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

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Screening/Baseline
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

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Week 1
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

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Week 2
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

  1. - Trace
  2. - Mild
  3. - Moderate
  4. - Marked
  5. - Severe
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stiefel, a GSK Company

Collaborators

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2009

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 5, 2009

Study Registration Dates

First Submitted

April 29, 2009

First Submitted That Met QC Criteria

April 30, 2009

First Posted (Estimate)

May 1, 2009

Study Record Updates

Last Update Posted (Actual)

May 24, 2017

Last Update Submitted That Met QC Criteria

May 19, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114679

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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