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This is a multicenter, randomized, single-blinded (investigator's blinded), active-controlled (clindamycin [CLDM] 1% gel), parallel-group study in Japanese subjects with acne vulgaris to demonstrate the efficacy of GSK2585823 (CLDM 1%-benzoyl peroxide [BPO] 3% gel) when applied once or twice daily for 12 weeks. This study will also evaluate the safety of GSK2585823 when applied topically either once or twice daily for 12 weeks.
Main inclusion criteria will be 12 to 45 years of age, who have an Investigator Static Global Assessment (ISGA) score of 2 or greater at baseline visit, and have both 17 to 60 facial inflammatory lesions (papules plus pustules) and 20 to 150 facial non-inflammatory lesions (open and closed comedones), including nasal lesions. The primary objectives are to demonstrate the superiority of GSK2585823 twice daily to CLDM twice daily in total lesion counts, and to demonstrate the non-inferiority of GSK2585823 once daily to CLDM twice daily in total lesion counts. The secondary objectives are to demonstrate the non-inferiority of GSK2585823 once daily to CLDM twice daily in inflammatory lesion counts, and to evaluate the efficacy of GSK2585823 once or twice daily compared with CLDM twice daily at each visit. A total of 800 subjects will be enrolled and randomly assigned to one of the groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK2585823(CLDM 1%-BPO 3% gel) once daily | Experimental | Subjects will apply in a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin). Also, the dose regimen will be once daily in the evening/bedtime. |
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| GSK2585823(CLDM 1%-BPO 3% gel) twice daily | Experimental | Subjects will apply in a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin). Also, the dose regimen will be twice daily in the morning and evening/bedtime. |
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| CLDM 1% gel twice daily | Active Comparator | Subjects will apply in a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin). Also, the dose regimen will be twice daily in the morning and evening/bedtime. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2585823(CLDM 1%-BPO 3% gel) | Drug | Topical gel in 1 g containing clindamycin 10 mg and benzoyl peroxide 30 mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline to Week 12 in Total Lesion Counts. | The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from post-randomization value at Week 12. | Baseline (Day 1) and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts | The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points. |
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Inclusion Criteria:
A) A minimum of 17 but not more than 60 inflammatory lesions (papules/pustules), including nasal lesions.
And B) A minimum of 20 but not more than 150 non-inflammatory lesions (open/closed comedones), including nasal lesions.
Exclusion Criteria:
Have any nodule-cystic lesions at baseline.
Are pregnant or breast-feeding.
Have a history or presence of regional enteritis, inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea or antibiotic-associated colitis) or similar symptoms.
Used any of the following agents on the face within the previous 2 weeks:Topical antibiotics (or systemic antibiotics);Topical anti-acne medications (e.g., BPO, azelaic acid, resorcinol, salicylates);Abradants, facials, or peels containing glycolic or other acids;Masks, washes or soaps containing BPO, sulfacetamide sodium, or salicylic acid;Non-mild facial cleansers (e.g., facial scrub, cleansers containing agents with anti-inflammatory action); Moisturizers that contain retinol, salicylic acid, or α- or β-hydroxy acids;Astringents and toner (Subjects are allowed to enroll in this study, if the subject has been on treatment for more than 2 consecutive weeks prior to start of investigational product use).
Used the following agents on the face or performed the following procedure within the previous 4 weeks:Topical corticosteroids (Use of inhaled, intra-articular, or intra-lesional steroids other than for facial acne is acceptable);Facial procedure (such as chemical or laser peel, microdermabrasion, blue light treatment, etc.).
Used systemic retinoids within the previous 6 months or topical retinoids on the face within the previous 6 weeks.
Received treatment with estrogens, androgens, or anti-androgenic agents within the previous 12 weeks (Subjects who have been treated with the above agents for more than 12 consecutive weeks prior to start of investigational product are allowed to enrol as long as they do not expect to change dose, drug, or discontinue use during the study).
Used any medication that in the opinion of the investigator may affect this clinical study or evaluation of the study.
Plan to use medications that are reported to exacerbate acne (e.g., mega-doses of certain vitamins, such as vitamin D [>2000 IU/day] and vitamin B12 [>1 mg/day], corticosteroids*, androgens, haloperidol, halogens [e.g., iodide and bromide], lithium, hydantoin, and phenobarbital).
*: except the using of topical corticosteroids (e.g., inhaled, intra-articular, or intra-lesional steroids) other than for facial acne.
Have a known hypersensitivity or have had previous allergic reaction to any of the components of the investigational product.
Used any investigational therapy within the previous 12 weeks, or plan to participate in another clinical study at the same time.
Participated in Japanese clinical studies planned by GlaxoSmithKline K.K. in the development of investigational products for acne vulgaris.
Are currently abusing drugs or alcohol.
Have a significant medical history of being immunocompromised.
People as follows and the family members:Employees of GlaxoSmithKline, contract research organization (CRO) or site management organization (SMO);Investigators.
Have other conditions that would put the subject at unacceptable risk for participation in the study.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Chiba | 273-0046 | Japan | |||
| GSK Investigational Site |
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A total of 800 Japanese participants across 26 investigational centers in Japan, with Acne Vulgaris were enrolled in this study. The study was conducted from 27 September 2011 - 02 August 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK2585823 Once Daily | Participants were instructed to apply GSK2585823 (Topical gel in 1 gram (g) containing clindamycin (CLDM) 10 milligram (mg) and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU (Finger Tip Unit). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| CLDM 1% gel twice daily | Drug | Topical gel containing clindamycin 10 mg/1 g gel |
|
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| Baseline (Day 1) and Weeks 1, 2, 4, and 8 |
| Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points. | Baseline (Day 1) and Weeks 1, 2, 4, 8, and 12 |
| Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.( Weeks 1, 2, 4, 8 and 12) | Baseline (Day 1) and Weeks 1, 2, 4, 8, and 12 |
| Percentage of Participants With a Minimum 2-grade Improvement From Baseline to Week 12 in Investigator's Static Global Assessment (ISGA) Score | Proportion of participants with at least a 2-Grade Improvement in ISGA was reported using a 5 point scale which indicates Score 0 (Clear): skin with no inflammatory or non-inflammatory lesions, Score 1 (Almost Clear): rare non-inflammatory lesions with no more than rare papules, Score 2 (Mild): greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions), Score 3 (Moderate): greater than Grade 2, many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion, Score 4 (Severe): greater than Grade 3, 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 investigator assessed ISGA score at baseline (Week 0/Day 1) and Weeks 1, 2, 4, 8, and 12. The area evaluated ISGA was limited to the face. | Baseline (Day 1) and Week 12 |
| Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12 | Proportion of participants with at least a 2-Grade Improvement in ISGA was reported using a 5 point scale which indicates Score 0 (Clear): skin with no inflammatory or non-inflammatory lesions, Score 1 (Almost Clear): rare non-inflammatory lesions with no more than rare papules, Score 2 (Mild): greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions), Score 3 (Moderate): greater than Grade 2, many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion, Score 4 (Severe): greater than Grade 3, 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 investigator assessed ISGA score at baseline (Week 0/Day 1) and Weeks 1, 2, 4, 8, and 12. The area evaluated ISGA was limited to the face. | Week 1, 2, 4, 8, and 12 |
| Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions | The percentage of participants who had reduction in total lesions (inflammatory and non-inflammatory) of at least 50 percent from Baseline at Weeks 1, 2, 4, 8, and 12 was measured. | Baseline (Day 1) and Week 1, 2, 4, 8, and 12 |
| Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism). MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism) for the susceptibility of clinical isolates (Propionibacterium acnes before and after application of the CLDM and NDFX was reported. MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis. | Baseline (Day 1) and Week12 |
| Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Erythema (redness), dryness, and peeling, were evaluated independently by the investigator on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Day 1 was Baseline and Change from Baseline was calculated by subtracting Baseline value from value at specified time points (Week 1, 2, 4, 8, and 12). | Baseline (Day 1) and Week 1, 2, 4, 8, and 12 |
| Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Burning/stinging, itching were evaluated independently by the participant on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Day 1 was Baseline and Change from Baseline was calculated by subtracting Baseline value from value at specified time points (Week 1, 2, 4, 8, and 12). | Baseline (Day 1) and Week 1, 2, 4, 8 and 12 |
| Hokkaido |
| 002-8022 |
| Japan |
| GSK Investigational Site | Hokkaido | 003-0833 | Japan |
| GSK Investigational Site | Hokkaido | 004-0074 | Japan |
| GSK Investigational Site | Hokkaido | 004-0876 | Japan |
| GSK Investigational Site | Hokkaido | 006-0022 | Japan |
| GSK Investigational Site | Hokkaido | 060-0063 | Japan |
| GSK Investigational Site | Hokkaido | 062-0042 | Japan |
| GSK Investigational Site | Hokkaido | 064-0915 | Japan |
| GSK Investigational Site | Hokkaido | 066-0021 | Japan |
| GSK Investigational Site | Hokkaido | 066-0064 | Japan |
| GSK Investigational Site | Hokkaido | 069-0813 | Japan |
| GSK Investigational Site | Hokkaido | 090-0832 | Japan |
| GSK Investigational Site | Hokkaido | 093-0016 | Japan |
| GSK Investigational Site | Kanagawa | 211-0063 | Japan |
| GSK Investigational Site | Kanagawa | 221-0825 | Japan |
| GSK Investigational Site | Osaka | 532-0026 | Japan |
| GSK Investigational Site | Osaka | 559-0017 | Japan |
| GSK Investigational Site | Osaka | 572-0838 | Japan |
| GSK Investigational Site | Osaka | 593-8324 | Japan |
| GSK Investigational Site | Saitama | 350-1305 | Japan |
| GSK Investigational Site | Tokyo | 111-0053 | Japan |
| GSK Investigational Site | Tokyo | 141-0031 | Japan |
| GSK Investigational Site | Tokyo | 150-0021 | Japan |
| GSK Investigational Site | Tokyo | 169-0075 | Japan |
| GSK Investigational Site | Tokyo | 194-0013 | Japan |
| FG001 | GSK2585823 Twice Daily | Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. |
| FG002 | CLDM Twice Daily | Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-treat (ITT) population comprised all randomized participants who received at least one application of investigational product. One participant excluded was randomized but was not administered study drug. 799 participant were included in the ITT population.
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK2585823 Once Daily | Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. |
| BG001 | GSK2585823 Twice Daily | Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. |
| BG002 | CLDM Twice Daily | Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. |
| BG003 | 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | 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 | Absolute Change From Baseline to Week 12 in Total Lesion Counts. | The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from post-randomization value at Week 12. | ITT population. Only those participants available at the indicated time points were analyzed. | Posted | Least Squares Mean | Standard Error | lesion count | Baseline (Day 1) and Week 12 |
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| Secondary | Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts | The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points. | ITT population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | lesion count | Baseline (Day 1) and Weeks 1, 2, 4, and 8 |
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| Secondary | Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts | The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points. | ITT population. Only those participants available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Lesion count | Baseline (Day 1) and Weeks 1, 2, 4, 8, and 12 |
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| Secondary | Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts | The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.( Weeks 1, 2, 4, 8 and 12) | ITT population. Only those participants available at the specified time points were analyzed. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline (Day 1) and Weeks 1, 2, 4, 8, and 12 |
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| Secondary | Percentage of Participants With a Minimum 2-grade Improvement From Baseline to Week 12 in Investigator's Static Global Assessment (ISGA) Score | Proportion of participants with at least a 2-Grade Improvement in ISGA was reported using a 5 point scale which indicates Score 0 (Clear): skin with no inflammatory or non-inflammatory lesions, Score 1 (Almost Clear): rare non-inflammatory lesions with no more than rare papules, Score 2 (Mild): greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions), Score 3 (Moderate): greater than Grade 2, many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion, Score 4 (Severe): greater than Grade 3, 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 investigator assessed ISGA score at baseline (Week 0/Day 1) and Weeks 1, 2, 4, 8, and 12. The area evaluated ISGA was limited to the face. | ITT population. Only those participants available at the indicated time points were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline (Day 1) and Week 12 |
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| Secondary | Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12 | Proportion of participants with at least a 2-Grade Improvement in ISGA was reported using a 5 point scale which indicates Score 0 (Clear): skin with no inflammatory or non-inflammatory lesions, Score 1 (Almost Clear): rare non-inflammatory lesions with no more than rare papules, Score 2 (Mild): greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions), Score 3 (Moderate): greater than Grade 2, many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion, Score 4 (Severe): greater than Grade 3, 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 investigator assessed ISGA score at baseline (Week 0/Day 1) and Weeks 1, 2, 4, 8, and 12. The area evaluated ISGA was limited to the face. | ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 1, 2, 4, 8, and 12 |
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| Secondary | Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions | The percentage of participants who had reduction in total lesions (inflammatory and non-inflammatory) of at least 50 percent from Baseline at Weeks 1, 2, 4, 8, and 12 was measured. | ITT population. Only those participants available at the indicated time points were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline (Day 1) and Week 1, 2, 4, 8, and 12 |
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| Secondary | Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX) | MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism). MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism) for the susceptibility of clinical isolates (Propionibacterium acnes before and after application of the CLDM and NDFX was reported. MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis. | ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). | Posted | Number | Micrograms/milliliter | Baseline (Day 1) and Week12 |
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| Secondary | Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12 | Erythema (redness), dryness, and peeling, were evaluated independently by the investigator on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Day 1 was Baseline and Change from Baseline was calculated by subtracting Baseline value from value at specified time points (Week 1, 2, 4, 8, and 12). | ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). | Posted | Mean | Standard Deviation | Score on scale | Baseline (Day 1) and Week 1, 2, 4, 8, and 12 |
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| Secondary | Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12 | Burning/stinging, itching were evaluated independently by the participant on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Day 1 was Baseline and Change from Baseline was calculated by subtracting Baseline value from value at specified time points (Week 1, 2, 4, 8, and 12). | ITT population. Only those participants available at the specified time points were analyzed (represented by n=X. X, X in the category titles). | Posted | Mean | Standard Deviation | Score on scale | Baseline (Day 1) and Week 1, 2, 4, 8 and 12 |
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Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
ITT population was used.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GSK2585823 Once Daily | Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. | 0 | 204 | 0 | 204 | 108 | 204 |
| EG001 | GSK2585823 Twice Daily | Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. | 0 | 296 | 0 | 296 | 163 | 296 |
| EG002 | CLDM Twice Daily | Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. | 0 | 299 | 0 | 299 | 110 | 299 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyshidrosis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Solar dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Xeroderma | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Asteatosis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dandruff | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Eczema nummular | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pityriasis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Infected dermal cyst | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Pericoronitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Glucose urine present | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nodule | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Fractured coccyx | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Lip dry | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Radicular cyst | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Erythema of eyelid | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Eyelid irritation | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Eczema eyelids | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Eye inflammation | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Eyelids pruritus | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 15.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Mean Difference (Net) |
| -8.2 |
| 2-Sided |
| 95 |
| -12.9 |
| -3.6 |
| Non-Inferiority |
If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established |
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. |
| OG002 | CLDM Twice Daily | Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. |
|
|
| GSK2585823 Twice Daily |
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. |
| OG002 | CLDM Twice Daily | Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. |
|
|
|
| GSK2585823 Twice Daily |
Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. |
| OG002 | CLDM Twice Daily | Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. |
|
|
|
| OG001 | GSK2585823 Twice Daily | Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. |
| OG002 | CLDM Twice Daily | Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. |
|
|
|
| OG001 | GSK2585823 Twice Daily | Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. |
| OG002 | CLDM Twice Daily | Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. |
|
|
|
Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
|
|
|
| OG002 | CLDM Twice Daily | Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. |
|
|
| OG002 | CLDM Twice Daily | Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. |
|
|
| OG002 | CLDM Twice Daily | Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU. |
|
|