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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin vs. Benzoyl peroxide used in combination with clindamycin and doxycycline in the treatment of moderate acne
To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin vs. Benzoyl peroxide used in combination with clindamycin and doxycycline once daily in the treatment of moderate acne
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BPO with clindamycin foam | Active Comparator | Benzoyl peroxide (BPO) wash with clindamycin foam |
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| BPO + clindamycin foam + doxycycline | Active Comparator | Benzoyl peroxide (BPO) wash with clindamycin foam and doxycycline capsules |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benzoyl peroxide with clindamycin | Drug | Benzoyl peroxide wash - Clindamycin foam |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Inflammatory Acne Lesions From Baseline to Week 16 | Percent change from baseline to week 16 in inflammatory acne lesions (pustules/papules)(chest and back) | Baseline, Week 16 |
| Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16. | Percent change in Non-inflammatory acne lesions (whiteheads and blackheads)(chest and back) from baseline to week 16. | Baseline, Week 16 |
| Percent Change in Total Acne Lesion Counts From Baseline to Week 16 | Percent change from baseline to week 16 in total acne lesions (inflammatory + non-inflammatory) | Baseline, Week 16 |
| Change in Investigator Global Assessment (IGA) | Change in Investigator Global Assessment (IGA) Average values chest and back. IGA scale: 0 - Clear 0.5 - Clear/almost clear
3.5- Moderate/Severe | Baseline, Weeks 4, 8,12, and 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent (%) Change in Inflammatory Lesion Counts (Chest and Back) From Baseline to Week 12 | Percent change in inflammatory lesion counts (chest and back)from Baseline to Week 12 | Baseline, Week 12 |
| Percent Change in Non-inflammatory Lesions (Chest and Back) From Baseline to Week 12 |
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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 |
|---|---|---|---|---|---|---|
| Center for Dermatology, Cosmetic and Laser Surgery | Fremont | California | 94538 | United States | ||
| Las Vegas Skin & Cancer Clinic |
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Recruitment period: First Subject Enrolled May 2008, Last Subject completed August 28, 2008.
Types of location: Dermatology Research Center
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| ID | Title | Description |
|---|---|---|
| FG000 | Benzoyl Peroxide Wash -Clindamycin Foam | Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. |
| FG001 | Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Benzoyl peroxide with clindamycin and doxycycline | Drug | Benzoyl peroxide wash - Clindamycin foam - Doxycycline capsules |
|
|
Percent change in non-inflammatory lesions (chest and back) from baseline to Week 12 |
| Baseline, Week 12 |
| Percent Change in Total Lesions (Chest and Back) From Baseline to Week 12 | Percent change in total lesions (chest and back) from baseline to Week 12 | Week 12 |
| Percentage of Particpants With IGA Score at Week 16 | Investigator Global Assessment (IGA) at Week 16 based on the Investigator Global Assessment IGA: 0 - Clear 0.5 - Clear/almost clear
3.5- Moderate/Severe | Baseline, Week 16 |
| Las Vegas |
| Nevada |
| 89129 |
| United States |
Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Benzoyl Peroxide Wash -Clindamycin Foam | Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. |
| BG001 | Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| 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 | Percent Change in Inflammatory Acne Lesions From Baseline to Week 16 | Percent change from baseline to week 16 in inflammatory acne lesions (pustules/papules)(chest and back) | ITT | Posted | Mean | Standard Deviation | Percent change | Baseline, Week 16 |
|
|
| ||||||||||||||||||||||||||||
| Primary | Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16. | Percent change in Non-inflammatory acne lesions (whiteheads and blackheads)(chest and back) from baseline to week 16. | ITT | Posted | Mean | Standard Deviation | Percent Change | Baseline, Week 16 |
|
| |||||||||||||||||||||||||||||
| Primary | Percent Change in Total Acne Lesion Counts From Baseline to Week 16 | Percent change from baseline to week 16 in total acne lesions (inflammatory + non-inflammatory) | ITT | Posted | Mean | Standard Deviation | Percent Change | Baseline, Week 16 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percent (%) Change in Inflammatory Lesion Counts (Chest and Back) From Baseline to Week 12 | Percent change in inflammatory lesion counts (chest and back)from Baseline to Week 12 | ITT | Posted | Mean | Standard Deviation | Percent Change | Baseline, Week 12 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percent Change in Non-inflammatory Lesions (Chest and Back) From Baseline to Week 12 | Percent change in non-inflammatory lesions (chest and back) from baseline to Week 12 | ITT | Posted | Mean | Standard Deviation | Percent change | Baseline, Week 12 |
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| Secondary | Percent Change in Total Lesions (Chest and Back) From Baseline to Week 12 | Percent change in total lesions (chest and back) from baseline to Week 12 | ITT | Posted | Mean | Standard Deviation | Percent change | Week 12 |
|
| |||||||||||||||||||||||||||||
| Primary | Change in Investigator Global Assessment (IGA) | Change in Investigator Global Assessment (IGA) Average values chest and back. IGA scale: 0 - Clear 0.5 - Clear/almost clear
3.5- Moderate/Severe | ITT | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Weeks 4, 8,12, and 16 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Particpants With IGA Score at Week 16 | Investigator Global Assessment (IGA) at Week 16 based on the Investigator Global Assessment IGA: 0 - Clear 0.5 - Clear/almost clear
3.5- Moderate/Severe | Subjects who completed week 16 | Posted | Number | Percent of participants | Baseline, Week 16 |
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16 weeks
Subjects who had visits at the first visit (Week 4) after baseline had AEs recorded.
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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 | Benzoyl Peroxide Wash -Clindamycin Foam | Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. | 0 | 13 | 4 | 13 | ||
| EG001 | Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules | Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day. | 0 | 14 | 4 | 14 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomach flu | Infections and infestations | not used | Non-systematic Assessment |
| |
| Cough | Infections and infestations | not used | Non-systematic Assessment |
| |
| Cold/ Cold symptoms | Infections and infestations | not used | Non-systematic Assessment |
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| Headache | Nervous system disorders | not used | Non-systematic Assessment |
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| Fever | Infections and infestations | not used | Non-systematic Assessment |
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| Nausea/ vomiting | Infections and infestations | not used | Non-systematic Assessment |
| |
| Dizziness | Ear and labyrinth disorders | not used | Non-systematic Assessment |
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Small sample size did not provide adequate power. Even with the limited sample size, total lesion counts provides a more reliable view of the study data due to the greater number of lesions to work with.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| 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 |
|---|---|
| D001585 | Benzoyl Peroxide |
| D002981 | Clindamycin |
| C000626399 | Acne RA-1,2 |
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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| Male |
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| Asian |
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| Hispanic |
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| Black or African American |
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