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

This study has been completed.

Study NCT00689117 Information provided by GlaxoSmithKline

First Received on May 24, 2008. Last Updated on September 22, 2011 History of Changes

Results First Received: November 2, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Acne Vulgaris Acne
Interventions:	Drug: CT Gel Drug: Clindamycin Gel (clindamycin ) Drug: Tretinoin Gel (tretinoin) Drug: Vehicle Gel

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
CT Gel	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 Gel	Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
Tretinoin Gel	Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
Vehicle Gel	Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks

Participant Flow: Overall Study

	CT Gel	Clindamycin Gel	Tretinoin Gel	Vehicle Gel
STARTED	476	467	464	242
COMPLETED	414	416	405	211
NOT COMPLETED	62	51	59	31
Adverse Event	6	0	5	0
Lost to Follow-up	26	19	17	11
Lack of Efficacy	1	2	2	2
Non-Compliance with Study Treatment	3	3	3	1
Withdrawal by Subject	19	18	26	13
Unable to Comply with Visit Schedule	0	0	1	1
Inclusion/Exclusion Criteria Not Met	1	2	0	0
Non-compliance with Treatment Regimen	0	1	0	0
Change/Discontinuation of Birth Control	1	1	1	0
Use of Prohibitive Medication	2	1	3	0
Pregnancy	0	2	0	2
Incarceration	2	0	0	0
Fear of Birth Defects	0	0	1	0
Transportation	1	0	0	0
Patient Withdrew from Study	0	0	0	1
Personal Reason	0	1	0	0
Dispensing Error	0	1	0	0

Baseline Characteristics

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Reporting Groups

	Description
CT Gel	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 Gel	Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
Tretinoin Gel	Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
Vehicle Gel	Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks

Baseline Measures

	CT Gel	Clindamycin Gel	Tretinoin Gel	Vehicle Gel	Total
Number of Participants [units: participants]	476	467	464	242	1649
Age [units: years] Mean ± Standard Deviation	20.8 ± 8.5	20.2 ± 8.1	20.2 ± 7.7	20.6 ± 8.4	20.4 ± 8.1
Gender [units: participants]
Female	269	266	264	153	952
Male	207	201	200	89	697
Race/Ethnicity, Customized [units: participants]
American Indian or Alaska Native	4	4	4	3	15
Asian	8	8	11	5	32
Black	94	85	103	51	333
Multiracial	12	16	19	5	52
Native Hawaiian/Other Pacific Islander	0	4	2	1	7
White	358	349	324	176	1207
Missing	0	1	1	1	3

Outcome Measures

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1. Primary:

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

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2. Primary:

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 [ Time Frame: Baseline, Week 12 ]

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3. Secondary:

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

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4. Secondary:

The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12 [ Time Frame: Week 12 ]

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5. Secondary:

The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12 [ Time Frame: Week 12 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00689117 History of Changes
Other Study ID Numbers:	114681, W0265-03
Study First Received:	May 24, 2008
Results First Received:	November 2, 2010
Last Updated:	September 22, 2011
Health Authority:	Canada: Health Canada; United States: Food and Drug Administration