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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of this study is to compare the effectiveness of two marketed products in subjects with facial acne vulgaris
Multiple physiopathological factors have been associated with acne vulgaris. Drug combinations are frequently used to address these factors and to improve efficacy in the treatment of acne. The current study proposes to compare a fixed-dose (once-daily) combination gel product containing benzoyl peroxide (BPO)and clindamycin against a fixed-dose (once-daily) combination gel product containing BPO and adapalene for the treatment of facial acne vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epiduo Gel | Active Comparator | Epiduo Gel (combination of 0.1% adapalene and 2.5% benzoyl peroxide (BPO) in a gel preparation). |
|
| Duac Gel | Experimental | Duac Akne Gel (combination of 1% clindamycin phosphate and 5% benzoyl peroxide (BPO) in a gel preparation). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epiduo Gel | Drug | Epiduo Gel (combination of 0.1% adapalene and 2.5% benzoyl peroxide (BPO) in a gel preparation). Treatments administered once-daily in the evening for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in inflammatory lesion count from Baseline to Week 12 | The efficacy assessor performed a count of inflammatory lesions (papules and pustules, including nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Week 12. | Baseline (Day 1) and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who achieved treatment success, defined as improvement of 2 grades or more in their Investigator Static Global Assessment (ISGA) acne severity scale from Baseline to Week 12 | ISGA success was defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. The area considered for assessment must be confined to the face. Acne severity of the participant's face was assessed by the assessor using the ISGA scale, ranging from 0 to 5 where 0=Clear skin with no inflammatory or non-inflammatory lesions. ;1=almost clear: Rare non-inflammatory lesions with no more than one small inflammatory lesion ;2=mild: Some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions). ;3=moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion; 4=severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions and 5= Very Severe: Many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The higher score indicated more severe lesions. |
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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 |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Berlin | 14052 | Germany | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19911678 | Result | Zouboulis CC, Fischer TC, Wohlrab J, Barnard J, Alio AB. Study of the efficacy, tolerability, and safety of 2 fixed-dose combination gels in the management of acne vulgaris. Cutis. 2009 Oct;84(4):223-9. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 22, 2017 | |
| Reset | Mar 23, 2018 | |
| Release | May 2, 2018 |
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| Duac Gel | Drug | Duac Akne Gel (combination of 1% clindamycin phosphate and 5% benzoyl peroxide (BPO) in a gel preparation). Treatments administered once-daily in the evening for 12 weeks |
|
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| Week 12 |
| Time to 2-grade improvement in ISGA from Baseline | ISGA success was defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Time to ISGA success from Baseline was analyzed using Kaplan-Meier Estimate of time. Baseline was defined as the value at Day 1 (Visit 1). Participants with missing week 12 evaluations were considered failures. | Week 12 |
| Percent change in total lesion count from Baseline to week 12 | The efficacy assessor performed a count of total lesions at each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Week 12. | Baseline (Day 1) and Week 12 |
| Absolute change in inflammatory lesion count from Baseline to Weeks 1, 2, 4, 8 | The efficacy assessor performed a count of inflammatory lesions (papules and pustules, including nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Weeks 1, 2, 4, 8. | Baseline (Day 1) and Weeks 1, 2, 4, 8 |
| Absolute change in inflammatory lesion count from Baseline to Week 12. | The efficacy assessor performed a count of inflammatory lesions (papules and pustules, including nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Week 12. | Baseline (Day 1) and Week 12 |
| Absolute change in total lesion count from Baseline to Weeks 1, 2, 4, 8 | The efficacy assessor performed a count of total lesions at each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Weeks 1, 2, 4, 8. | Baseline (Day 1) and Weeks 1, 2, 4, 8 |
| Absolute change in total lesion count from Baseline to Week 12 | The efficacy assessor performed a count of total lesions at each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Week 12. | Baseline (Day 1) and Week 12 |
| Percentage of participants who achieved treatment success from Baseline to Weeks 1, 2, 4, and 8 | ISGA success was defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participant's face was assessed by the assessor using the ISGA scale, ranging from 0 to 5 where 0= Clear skin with no inflammatory or non-inflammatory lesions and 5= Very Severe: Many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The higher score indicated more severe lesions. The area considered for the ISGA was confined to the face. Data for percentage of participants who achieved treatment success from Baseline to Weeks 1, 2, 4, and 8 was not collected. | Weeks 1, 2, 4, and 8 |
| Absolute change in non-inflammatory lesion count from Baseline to Weeks 1 2, 4,8 | The efficacy assessor performed a count of non-inflammatory lesions (open and closed comedones, excluding nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Weeks 1, 2, 4, 8. | Baseline (Day 1) and Weeks 1,2,4,8 |
| Absolute change in non-inflammatory lesion count from Baseline to Week 12 | The efficacy assessor performed a count of non-inflammatory lesions (open and closed comedones, excluding nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Week 12. | Baseline (Day 1) and Week 12 |
| Percent change in non-inflammatory lesion count from Baseline to Weeks 1, 2, 4, 8 | The efficacy assessor performed a count of non-inflammatory lesions (open and closed comedones, excluding nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Weeks 1, 2, 4, 8. | Baseline (Day 1) and Weeks 1, 2, 4, 8 |
| Percent change in non-inflammatory lesion count from Baseline to Week 12 | The efficacy assessor performed a count of non-inflammatory lesions (open and closed comedones, excluding nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Week 12. | Baseline (Day 1) and Week 12 |
| Percent change in inflammatory lesion count from Baseline to Weeks 1, 2, 4, and 8 | The efficacy assessor performed a count of inflammatory lesions (papules and pustules, including nasal lesions) each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Weeks 1, 2, 4, and 8. | Baseline (Day 1) and Weeks 1, 2, 4, and 8 |
| Percent change in total lesion count from Baseline to Weeks 1, 2, 4, and 8 | The efficacy assessor performed a count of total lesions at each study visit. Lesion counts were confined to the face. Baseline was defined as the value at Day 1 (Visit 1). Change from Baseline was calculated by subtracting the Baseline from the post-randomization value at Weeks 1, 2, 4, and 8. | Baseline (Day 1) and Weeks 1, 2, 4, and 8 |
| Time to reach 50 percent reduction in inflammatory lesion counts from Baseline | Time to reach 50 percent reduction in inflammatory lesion counts (papules and pustules, including nasal lesions) from Baseline was analyzed using Kaplan-Meier Estimate of time. Baseline was defined as the value at Day 1 (Visit 1). | Week 12 |
| Time to reach 50 percent reduction in non-inflammatory lesion counts from Baseline | Time to reach 50 percent reduction in non-inflammatory lesion counts ((open and closed comedones, excluding nasal lesions) from Baseline was analyzed using Kaplan-Meier Estimate of time. Baseline was defined as the value at Day 1 (Visit 1). | Week 12 |
| Time to reach 50 percent reduction in total lesion counts from Baseline | Time to time to reach 50 percent reduction in total lesion counts from Baseline was analyzed using Kaplan-Meier Estimate of time. Baseline was defined as the value at Day 1 (Visit 1). | Week 12 |
| Percentage of participants who had a Subject's Global Change Assessment score (SGAC) of 0 or 1 at Weeks 1, 2, 4, 8, and 12 | SGCA is measured on a scale (Clear, Almost Clear, Mild, Moderate, Severe, Very Severe) with Clear being best and Very Severe being worst. The area considered for the ISGA was confined to the face. Data for percentage of participants who had a SGAC of 0 or 1 at Weeks 1, 2, 4, 8, and 12 was not collected. | Upto Week 12 |
| Berlin |
| 14169 |
| Germany |
| GSK Investigational Site | Bonn | 53105 | Germany |
| GSK Investigational Site | Dessau | 06847 | Germany |
| GSK Investigational Site | Dülmen | 48249 | Germany |
| GSK Investigational Site | Essen | 45122 | Germany |
| GSK Investigational Site | Frankfurt | 60590 | Germany |
| GSK Investigational Site | Giessen | 35392 | Germany |
| GSK Investigational Site | Halle | 06097 | Germany |
| GSK Investigational Site | Hamburg | 20246 | Germany |
| GSK Investigational Site | Kiel | 24148 | Germany |
| GSK Investigational Site | Landau | 76829 | Germany |
| GSK Investigational Site | Magdeburg | 39120 | Germany |
| GSK Investigational Site | München | 80337 | Germany |
| GSK Investigational Site | München | 80802 | Germany |
| GSK Investigational Site | Münster | 48149 | Germany |
| GSK Investigational Site | Potsdam | 14469 | Germany |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 22, 2017 | Mar 23, 2018 | |||
| May 2, 2018 | Aug 15, 2018 |
| 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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