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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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ClinicalTrials.gov Identifier: NCT00891982
Recruitment Status : Completed
First Posted : May 1, 2009
Results First Posted : July 25, 2011
Last Update Posted : May 24, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Actual Study Start Date : April 1, 2009
Actual Primary Completion Date : June 1, 2009
Actual Study Completion Date : June 5, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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 :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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


Eligibility Criteria
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Information from the National Library of Medicine

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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Publications:

Responsible Party: Stiefel, a GSK Company
ClinicalTrials.gov Identifier: NCT00891982     History of Changes
Other Study ID Numbers: 114679
First Posted: May 1, 2009    Key Record Dates
Results First Posted: July 25, 2011
Last Update Posted: May 24, 2017
Last Verified: May 2017

Keywords provided by GlaxoSmithKline ( Stiefel, a GSK Company ):
Acne Vulgaris

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