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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 (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT00891982
First received: April 29, 2009
Last updated: May 19, 2017
Last verified: May 2017
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
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Acne
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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


Secondary Outcome Measures:
  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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
Enrollment: 60
Actual Study Start Date: April 1, 2009
Study Completion Date: June 5, 2009
Primary Completion Date: June 1, 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)
Sexes Eligible for Study:   All
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: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:

Responsible Party: Stiefel, a GSK Company
ClinicalTrials.gov Identifier: NCT00891982     History of Changes
Other Study ID Numbers: 114679
Study First Received: April 29, 2009
Results First Received: October 6, 2010
Last Updated: May 19, 2017

Keywords provided by GlaxoSmithKline:
Acne Vulgaris

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Tretinoin
Benzoyl Peroxide
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
 Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 24, 2017