A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel

• Sponsor: Stiefel, a GSK Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00689117
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 1,649
• Locations: 32
• Arms: 4
• Duration (Months): 13
• Patients Per Site: 51.5
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

The purpose of this study is to demonstrate the safety and effectiveness of CT Gel in subjects with acne vulgaris. The hypothesis is that CT Gel is superior to Clindamycin Gel, Tretinoin Gel and Vehicle Gel for the treatment of acne vulgaris.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris; Acne	Drug: CT Gel; Drug: Clindamycin Gel (clindamycin ); Drug: Tretinoin Gel (tretinoin); Drug: Vehicle Gel	Phase 3

Detailed Description

CT Gel is a fixed-combination product that addresses the multifactorial factors of acne vulgaris pathogenesis. Based on numerous nonclinical pharmacology studies of each active ingredient, it is expected that this new product will have three biological actions: 1) comedolytic, 2) antimicrobial, and 3) anti-inflammatory.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1649 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 3 Multicenter, Randomized, Double-Blind, Active And Vehicle-Controlled Study Of The Safety And Efficacy Of CT Gel in Subjects With Acne Vulgaris
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 CT Gel	Drug: CT Gel; Topical gel consisting of clindamycin 1% and tretinoin 0.025%, applied once daily in the evening for 12 weeks
Active Comparator: 2 Clindamycin Gel (clindamycin)	Drug: Clindamycin Gel (clindamycin ); Clindamycin 1% gel applied topically once daily in the evening for 12 weeks
Active Comparator: 3 Tretinoin Gel (tretinoin)	Drug: Tretinoin Gel (tretinoin); Tretinoin 0.025% gel applied topically once daily in the evening for 12 weeks
Placebo Comparator: 4 Vehicle Gel	Drug: Vehicle Gel; Topical gel without clindamycin or tretinoin applied topically once daily in the evening for 12 weeks

Outcome Measures

Primary Outcome Measures

1. Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) [Baseline, Week 12]

   Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts.

2. The Percentage of Participants Who Had a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 [Baseline, Week 12]

   The ISGA is a static ("snap-shot") evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. Change is calculated as the Week 12 value minus the Baseline value.

Secondary Outcome Measures

1. Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12 [Baseline, Week 12]

   Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts.

2. The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12 [Week 12]

   The SGA score is a global evaluation of acne severity performed by participants at all visits and measured on a 5-point ordinal scale, where 0=My face is basically free of acne and 5=My face has blackheads and/or whiteheads. A score of 1=My face has several blackheads and/or whiteheads and small pimples, but there are no tender deep-seated bumps or cysts.

3. The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12 [Week 12]

   The ISGA is a static ("snap-shot") evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. A score of 1=Skin Almost Clear: rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyper-pigmented, though not pink-red) requiring no futher treatment in the Investigator's opinion.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female 12 years of age or older in good general health

• Investigator's Static Global Assessment (ISGA) score of 2 or greater at Baseline

Exclusion Criteria:

• Any nodulo-cystic lesions at Baseline

• Pregnancy or breast feeding

• History or presence of regional enteritis or inflammatory bowel disease or similar symptoms.

• Treatment with estrogens, including oral, implanted and topical contraceptives, androgens, or anti-androgenic agents for 12 weeks or less prior to study start.

• Use of topical anti-acne medications within the past 2 weeks.

• Use of topical or systemic antibiotics on the face within the past 2 weeks.

• Use of topical or systemic corticosteroids within the past 2 weeks.

• Use of systemic retinoids within the past 3 months.

• Use of astringents, toners and skin cleansers for less than 2 weeks prior to the start of the study.

• Concomitant use of facial product containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or moisturizers containing retinol, salicylic or α- or β-hydroxy acids.

• Concomitant use of mega-doses of certain vitamins, such as vitamin D (>2000IU QD) vitamin B12, haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.

• Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 2 weeks or during the study.

• Concomitant use of tanning booths or sunbathing.

• Known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, retinoids or excipients of the study product

• A significant medical history of or are currently immunocompromised

• Current drug or alcohol abuse. (Drug screening not required.)

• Use of any investigational therapy within 4 weeks of enrollment.

• Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radiant Research	Birmingham	Alabama	United States	35209
2	Coastal Clinical Research, Inc.	Mobile	Alabama	United States	33608
3	Burke Pharmaceutical Research	Hot Springs	Arkansas	United States	71913
4	Center for Dermatology, Cosmetic and Laser Surgery	Fremont	California	United States	94538
5	University Clinical Trials	San Diego	California	United States	92103
6	Longmont Medical Research Network	Longmont	Colorado	United States	80501
7	FXM Research Corporation	Miami	Florida	United States	33175
8	FXM Research - Miramar	Miramar	Florida	United States	33027
9	Advanced Dermatolgy & Cosemtic Surgery	Ormond Beach	Florida	United States	32174
10	Dermatology Specialists	Louisville	Kentucky	United States	40202
11	Massachusettes General Hospital - Clinical Unit for Research Trials in Skin	Boston	Massachusetts	United States	02114
12	University of Michigan	Ann Arbor	Michigan	United States	48109
13	Henry Ford Medical Center	Detroit	Michigan	United States	48202
14	Minnesota Clinical Study Center	Fridley	Minnesota	United States	55432
15	Skin Specialists, P.C.	Omaha	Nebraska	United States	68144
16	Academic Dermatology Research	Albuquerque	New Mexico	United States	87106
17	Dermatology Research Associates, Inc.	Cincinnati	Ohio	United States	45230
18	Yardley Dermatology Associates	Yardley	Pennsylvania	United States	19067
19	Clinical Partners, LLC	Johnston	Rhode Island	United States	02919
20	Dermatology Associates of Knoxville, P.C.	Knoxville	Tennessee	United States	37934
21	Tennessee Clinical Research	Nashville	Tennessee	United States	37215
22	DermResearch, Inc.	Austin	Texas	United States	78759
23	J & S Studies, Inc.	College Station	Texas	United States	77840
24	The Hair and Skin Research Treatment Center	Dallas	Texas	United States	75246
25	Dermatology Research Center, Inc.	Salt Lake City	Utah	United States	84124
26	Premier Clincial Research	Spokane	Washington	United States	99204
27	Advanced Healthcare	Milwaukee	Wisconsin	United States	53209
28	Dermatology And Skin Centre	Belize City		Belize
29	Dr. Moguel's Clinic	Belize City		Belize
30	K. Papp Clinical Research, Inc.	Waterloo	Ontario	Canada	N2J 1C4
31	Windsor Clinical Research Center, Inc.	Windsor	Ontario	Canada	N8W 5L7
32	Innovaderm Research, Inc.	Montreal	Quebec	Canada	H2K 4L5

Sponsors and Collaborators

• Stiefel, a GSK Company
• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stiefel, a GSK Company
• ClinicalTrials.gov Identifier: NCT00689117
• Other Study ID Numbers: 114681; W0265-03
• First Posted: Jun 3, 2008
• Last Update Posted: May 30, 2017
• Last Verified: May 1, 2017

• Keywords provided by Stiefel, a GSK Company: Acne Vulgaris; Acne
• Additional relevant MeSH terms: Acne Vulgaris; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Tretinoin

Study Results

Participant Flow

Arm/Group Title	CT Gel	Clindamycin Gel	Tretinoin Gel	Vehicle Gel
Arm/Group Description	Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks	Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks	Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks	Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
Period Title: Overall Study
STARTED	476	467	464	242
COMPLETED	414	416	405	211
NOT COMPLETED	62	51	59	31

Baseline Characteristics

Arm/Group Title	CT Gel	Clindamycin Gel	Tretinoin Gel	Vehicle Gel	Total
Arm/Group Description	Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks	Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks	Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks	Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks	Total of all reporting groups
Overall Participants	476	467	464	242	1649
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	20.8 (8.5)	20.2 (8.1)	20.2 (7.7)	20.6 (8.4)	20.4 (8.1)
Sex: Female, Male (Count of Participants)
Female	269 56.5%	266 57%	264 56.9%	153 63.2%	952 57.7%
Male	207 43.5%	201 43%	200 43.1%	89 36.8%	697 42.3%
Race/Ethnicity, Customized (participants) [Number]
American Indian or Alaska Native	4 0.8%	4 0.9%	4 0.9%	3 1.2%	15 0.9%
Asian	8 1.7%	8 1.7%	11 2.4%	5 2.1%	32 1.9%
Black	94 19.7%	85 18.2%	103 22.2%	51 21.1%	333 20.2%
Multiracial	12 2.5%	16 3.4%	19 4.1%	5 2.1%	52 3.2%
Native Hawaiian/Other Pacific Islander	0 0%	4 0.9%	2 0.4%	1 0.4%	7 0.4%
White	358 75.2%	349 74.7%	324 69.8%	176 72.7%	1207 73.2%
Missing	0 0%	1 0.2%	1 0.2%	1 0.4%	3 0.2%

Outcome Measures

1. Primary Outcome

Title	Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study)
Description	Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: all participants who were randomized to and received at least one application of study product.

Arm/Group Title	CT Gel	Clindamycin Gel	Tretinoin Gel	Vehicle Gel
Arm/Group Description	Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks	Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks	Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks	Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
Measure Participants	476	467	464	242
Inflammatory Lesion Counts	-15.5 (10.33)	-14.5 (9.37)	-13.9 (11.05)	-11.1 (11.70)
Non-Inflammatory Lesion Counts	-23.2 (20.41)	-19.5 (19.72)	-22.1 (21.75)	-17.0 (20.58)
Total Lesion Counts	-38.7 (26.80)	-34.0 (25.16)	-36.0 (28.26)	-28.1 (27.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Clindamycin Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.063
	Comments	Inflammatory lesion count
	Method	Ranked ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Tretinoin Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments	Inflammatory lesion count
	Method	Ranked ANCOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Vehicle Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Inflammatory lesion count
	Method	Ranked ANCOVA
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Clindamycin Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments	Non-inflammatory lesion count
	Method	Ranked ANCOVA
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Tretinoin Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.550
	Comments	Non-inflammatory lesion count
	Method	Ranked ANCOVA
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Vehicle Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Non-inflammatory lesion count
	Method	Ranked ANCOVA
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Clindamycin Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Total lesion count
	Method	Ranked ANCOVA
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Tretinoin Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.016
	Comments	Total lesion count
	Method	Ranked ANCOVA
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Vehicle Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Total lesion count
	Method	Ranked ANCOVA
	Comments

2. Primary Outcome

Title	The Percentage of Participants Who Had a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
Description	The ISGA is a static ("snap-shot") evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. Change is calculated as the Week 12 value minus the Baseline value.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	CT Gel	Clindamycin Gel	Tretinoin Gel	Vehicle Gel
Arm/Group Description	Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks	Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks	Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks	Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
Measure Participants	476	467	464	242
Number [percentage of participants]	36.3 7.6%	26.6 5.7%	26.1 5.6%	20.2 8.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Clindamycin Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments	Data based on Data on File documenting FDA reanalysis request
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Tretinoin Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Data based on Data on File documenting FDA reanalysis request
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Vehicle Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Data based on Data on File documenting FDA reanalysis request
	Method	Cochran-Mantel-Haenszel
	Comments

3. Secondary Outcome

Title	Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12
Description	Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	CT Gel	Clindamycin Gel	Tretinoin Gel	Vehicle Gel
Arm/Group Description	Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks	Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks	Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks	Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
Measure Participants	476	467	464	242
Inflammatory Lesions	-60.5 (36.21)	-56.6 (44.99)	-54.5 (39.19)	-43.3 (44.9)
Non-Inflammatory Lesions	-51.1 (33.02)	-42.9 (36.6)	-47.3 (43.5)	-36.0 (39.14)
Total Lesions	-55.0 (30.47)	-49.0 (30.08)	-50.6 (34.82)	-39.1 (36.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Clindamycin Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.065
	Comments	Inflammatory lesion count
	Method	Ranked ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Tretinoin Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments	Inflammatory lesion count
	Method	Ranked ANCOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Vehicle Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Inflammatory lesion count
	Method	Ranked ANCOVA
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Clindamycin Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Non-inflammatory lesion count
	Method	Ranked ANCOVA
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Tretinoin Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.284
	Comments	Non-inflammatory lesion count
	Method	Ranked ANCOVA
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Vehicle Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Non-inflammatory lesion count
	Method	Ranked ANCOVA
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Clindamycin Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Total lesion count
	Method	Ranked ANCOVA
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Tretinoin Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.028
	Comments	Total lesion count
	Method	Ranked ANCOVA
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Vehicle Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Total lesion count
	Method	Ranked ANCOVA
	Comments

4. Secondary Outcome

Title	The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12
Description	The SGA score is a global evaluation of acne severity performed by participants at all visits and measured on a 5-point ordinal scale, where 0=My face is basically free of acne and 5=My face has blackheads and/or whiteheads. A score of 1=My face has several blackheads and/or whiteheads and small pimples, but there are no tender deep-seated bumps or cysts.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	CT Gel	Clindamycin Gel	Tretinoin Gel	Vehicle Gel
Arm/Group Description	Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks	Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks	Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks	Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
Measure Participants	476	467	464	242
Number [participants]	62 13%	60 12.8%	62 13.4%	50 20.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Clindamycin Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.671
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Tretinoin Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.919
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Vehicle Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

5. Secondary Outcome

Title	The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12
Description	The ISGA is a static ("snap-shot") evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. A score of 1=Skin Almost Clear: rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyper-pigmented, though not pink-red) requiring no futher treatment in the Investigator's opinion.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	CT Gel	Clindamycin Gel	Tretinoin Gel	Vehicle Gel
Arm/Group Description	Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks	Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks	Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks	Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
Measure Participants	476	467	464	242
Number [percentage of participants]	43.1 9.1%	36.6 7.8%	33.8 7.3%	22.7 9.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Clindamycin Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Tretinoin Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	CT Gel, Vehicle Gel
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Adverse Events

Arm/Group Title	CT Gel		Clindamycin Gel		Tretinoin Gel		Vehicle Gel
Arm/Group Description	Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks		Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks		Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks		Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
All Cause Mortality
	CT Gel		Clindamycin Gel		Tretinoin Gel		Vehicle Gel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	CT Gel		Clindamycin Gel		Tretinoin Gel		Vehicle Gel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/476 (0.2%)		1/467 (0.2%)		3/464 (0.6%)		1/242 (0.4%)
Gastrointestinal disorders
Abdominal pain	0/476 (0%)		1/467 (0.2%)		0/464 (0%)		0/242 (0%)
Infections and infestations
Bronchitis	0/476 (0%)		0/467 (0%)		0/464 (0%)		1/242 (0.4%)
Infectious mononucleosis	1/476 (0.2%)		0/467 (0%)		0/464 (0%)		0/242 (0%)
Injury, poisoning and procedural complications
Concussion	0/476 (0%)		0/467 (0%)		1/464 (0.2%)		0/242 (0%)
Psychiatric disorders
Suicide attempt	0/476 (0%)		0/467 (0%)		1/464 (0.2%)		0/242 (0%)
Reproductive system and breast disorders
Ovarian cyst	0/476 (0%)		0/467 (0%)		1/464 (0.2%)		0/242 (0%)
Other (Not Including Serious) Adverse Events
	CT Gel		Clindamycin Gel		Tretinoin Gel		Vehicle Gel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	27/476 (5.7%)		34/467 (7.3%)		27/464 (5.8%)		18/242 (7.4%)
Infections and infestations
Nasopharyngitis	27/476 (5.7%)		34/467 (7.3%)		27/464 (5.8%)		18/242 (7.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.