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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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00891982
First received: April 29, 2009
Last updated: June 23, 2011
Last verified: June 2011
History of Changes
  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
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
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
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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
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: June 23, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Acne Vulgaris

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Anti-Bacterial Agents
 Benzoyl Peroxide
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on May 23, 2013