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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of the study is to determine the development of microbial resistance when using one of two topical acne therapies for the treatment of facial acne vulgaris.
To investigate the development of microbial resistance when using one of two topical acne therapies for the treatment of moderate to moderately severe facial acne vulgaris. Clinical efficacy and tolerability will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duac gel | Active Comparator | Clindamycin and benzoyl peroxide gel |
|
| Ziana gel | Active Comparator | Clindamycin and tretinoin gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duac | Drug | Clindamycon and benzoyl peroxide topical gel once a day for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Median Change in Total Propionibacterium Acne (P.Acne) Counts | Median change in total colony forming units of propionibacterium acne (P.acne) will be counted. | Baseline, Weeks 2, 4, 8, 12, & 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Median Change in Clindamycin Resistant P. Acne. | Median change in total colony forming units of clindamycin resistant p. acne. | Baseline, Weeks 2, 4, 8, 12, 16 |
| Median Change in Erythromycin-resistant P. Acne Counts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Specialists, PSC | Louisville | Kentucky | 40202 | United States | ||
| Skin We Care Dermatology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20214175 | Result | Jackson JM, Fu JJ, Almekinder JL. A randomized, investigator-blinded trial to assess the antimicrobial efficacy of a benzoyl peroxide 5%/ clindamycin phosphate 1% gel compared with a clindamycin phosphate 1.2%/tretinoin 0.025% gel in the topical treatment of acne vulgaris. J Drugs Dermatol. 2010 Feb;9(2):131-6. |
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Clinical research center
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| ID | Title | Description |
|---|---|---|
| FG000 | Duac | Clindamycin and benzoyl peroxide topical gel |
| FG001 | Ziana | Clindamycin and topical tretinoin gel |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Duac | Clindamycin and benzoyl peroxide topical gel |
| BG001 | Ziana | Clindamycin and topical tretinoin gel |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Median Change in Total Propionibacterium Acne (P.Acne) Counts | Median change in total colony forming units of propionibacterium acne (P.acne) will be counted. | Posted | Median | Inter-Quartile Range | P. acne counts | Baseline, Weeks 2, 4, 8, 12, & 16 |
|
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Duac | Clindamycin and benzoyl peroxide topical gel |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Attention Deficit Disorder | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| C466951 | clindamycin phosphate benzoyl peroxide combination |
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| Ziana gel |
| Drug |
Clindamycin and tretinoin gel once a day for 12 weeks. |
|
Total colony forming units of erythromycin-resistant p. acnes.
| Baseline, Weeks 2, 4, 8, 12, and 16 |
| Median Change in Total Acne Lesions | Median Change in Total Acne Lesions | Baseline, Weeks 2, 4, 8, 12, and 16 |
| Median Change in Inflammatory Acne Lesion Counts | Median Change in Inflammatory Acne Lesion Counts | Baseline, Weeks 2, 4, 8, 12, and 16 |
| Median Change in Noninflammaotry Acne Counts | Median Change in Noninflammaotry Acne Counts | Baseline, Weeks 2, 4, 8, 12, and 16 |
| Mason |
| Ohio |
| 45040 |
| United States |
| Withdrawal by Subject |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Number | participants |
|
| Acne Lesion Counts | P. acne Lesion Counts | Mean | Standard Deviation | Acne Lesion Counts |
|
| Clinidamycin-resistant propionibacterium acne (P.acne) counts | Clinidamycin-resistant Colony Forming Unit Propionibacterium acne counts | Mean | Standard Deviation | Clinidamycin-resistant p. acne counts |
|
| Erythromycin-resistant lesion count | Erythromycin-resistant Colony forming Unit lesion count | Mean | Standard Deviation | Erythromycin-resistant lesion count |
|
| Propionibacterium acne counts | Mean colony forming unit P. acne counts | Mean | Standard Deviation | P. acne counts |
|
| Participants |
|
|
| Secondary | Median Change in Clindamycin Resistant P. Acne. | Median change in total colony forming units of clindamycin resistant p. acne. | ITT | Posted | Median | Inter-Quartile Range | Clindamycin- resistant P. acne counts | Baseline, Weeks 2, 4, 8, 12, 16 |
|
|
|
| Secondary | Median Change in Erythromycin-resistant P. Acne Counts | Total colony forming units of erythromycin-resistant p. acnes. | ITT | Posted | Median | Inter-Quartile Range | Erythromycin-resistant P. acne counts | Baseline, Weeks 2, 4, 8, 12, and 16 |
|
|
|
| Secondary | Median Change in Total Acne Lesions | Median Change in Total Acne Lesions | ITT | Posted | Median | Inter-Quartile Range | Total Acne Lesion Counts | Baseline, Weeks 2, 4, 8, 12, and 16 |
|
|
|
| Secondary | Median Change in Inflammatory Acne Lesion Counts | Median Change in Inflammatory Acne Lesion Counts | ITT | Posted | Median | Inter-Quartile Range | Lesion Counts | Baseline, Weeks 2, 4, 8, 12, and 16 |
|
|
|
| Secondary | Median Change in Noninflammaotry Acne Counts | Median Change in Noninflammaotry Acne Counts | Posted | Median | Inter-Quartile Range | Noninflammatory lesion counts | Baseline, Weeks 2, 4, 8, 12, and 16 |
|
|
|
| 0 |
| 27 |
| 5 |
| 27 |
| EG001 | Ziana | Clindamycin and topical tretinoin gel | 0 | 27 | 5 | 27 |
| Sinus Infection | Infections and infestations | Non-systematic Assessment |
|
| Gonorrhea | Infections and infestations | Non-systematic Assessment |
|
| Head Cold | Infections and infestations | Non-systematic Assessment |
|
| Oral Thrush | Infections and infestations | Non-systematic Assessment |
|
| Oily skin on face | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin surgery | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Surgery performed while on study |
|
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| Change from Baseline to Week 8 |
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| Change from Baseline to Week 12 |
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| Change from Baseline to Week 16 |
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| Change from Baseline to Week 8 |
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| Change from Baseline to Week 12 |
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| Change from Baseline to Week 16 |
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| Change from Baseline to Week 8 |
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| Change from Baseline to Week 12 |
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| Change from Baseline to Week 16 |
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| Change from Baseline to Week 8 |
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| Change from Baseline to Week 12 |
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| Change from Baseline to Week 16 |
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| Change from Baseline to Week 8 |
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| Change from Baseline to Week 12 |
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| Change from Baseline to Week 16 |
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