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Trial record 48 of 233 for:    acne AND Percent

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00689117
Recruitment Status : Completed
First Posted : June 3, 2008
Results First Posted : December 2, 2010
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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
Enrollment 1649
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CT Gel Clindamycin Gel Tretinoin Gel Vehicle Gel
Hide 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
Reason Not Completed
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
Arm/Group Title CT Gel Clindamycin Gel Tretinoin Gel Vehicle Gel Total
Hide 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 Number of Baseline Participants 476 467 464 242 1649
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 476 participants 467 participants 464 participants 242 participants 1649 participants
20.8  (8.5) 20.2  (8.1) 20.2  (7.7) 20.6  (8.4) 20.4  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 476 participants 467 participants 464 participants 242 participants 1649 participants
Female
269
  56.5%
266
  57.0%
264
  56.9%
153
  63.2%
952
  57.7%
Male
207
  43.5%
201
  43.0%
200
  43.1%
89
  36.8%
697
  42.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 476 participants 467 participants 464 participants 242 participants 1649 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
1.Primary Outcome
Title Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 476 467 464 242
Mean (Standard Deviation)
Unit of Measure: lesions
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CT Gel, Clindamycin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments Inflammatory lesion count
Method Ranked ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CT Gel, Tretinoin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments Inflammatory lesion count
Method Ranked ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CT Gel, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Inflammatory lesion count
Method Ranked ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection CT Gel, Clindamycin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments Non-inflammatory lesion count
Method Ranked ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection CT Gel, Tretinoin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.550
Comments Non-inflammatory lesion count
Method Ranked ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection CT Gel, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Non-inflammatory lesion count
Method Ranked ANCOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection CT Gel, Clindamycin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Total lesion count
Method Ranked ANCOVA
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection CT Gel, Tretinoin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments Total lesion count
Method Ranked ANCOVA
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection CT Gel, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Total lesion count
Method Ranked ANCOVA
Comments [Not Specified]
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title CT Gel Clindamycin Gel Tretinoin Gel Vehicle Gel
Hide 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
Overall Number of Participants Analyzed 476 467 464 242
Measure Type: Number
Unit of Measure: percentage of participants
36.3 26.6 26.1 20.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CT Gel, Clindamycin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Data based on Data on File documenting FDA reanalysis request
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CT Gel, Tretinoin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Data based on Data on File documenting FDA reanalysis request
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CT Gel, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Data based on Data on File documenting FDA reanalysis request
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title CT Gel Clindamycin Gel Tretinoin Gel Vehicle Gel
Hide 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
Overall Number of Participants Analyzed 476 467 464 242
Mean (Standard Deviation)
Unit of Measure: percent change
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CT Gel, Clindamycin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.065
Comments Inflammatory lesion count
Method Ranked ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CT Gel, Tretinoin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Inflammatory lesion count
Method Ranked ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CT Gel, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Inflammatory lesion count
Method Ranked ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection CT Gel, Clindamycin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Non-inflammatory lesion count
Method Ranked ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection CT Gel, Tretinoin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.284
Comments Non-inflammatory lesion count
Method Ranked ANCOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection CT Gel, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Non-inflammatory lesion count
Method Ranked ANCOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection CT Gel, Clindamycin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Total lesion count
Method Ranked ANCOVA
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection CT Gel, Tretinoin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments Total lesion count
Method Ranked ANCOVA
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection CT Gel, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Total lesion count
Method Ranked ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title CT Gel Clindamycin Gel Tretinoin Gel Vehicle Gel
Hide 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
Overall Number of Participants Analyzed 476 467 464 242
Measure Type: Number
Unit of Measure: participants
62 60 62 50
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CT Gel, Clindamycin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.671
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CT Gel, Tretinoin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.919
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CT Gel, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
5.Secondary Outcome
Title The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title CT Gel Clindamycin Gel Tretinoin Gel Vehicle Gel
Hide 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
Overall Number of Participants Analyzed 476 467 464 242
Measure Type: Number
Unit of Measure: percentage of participants
43.1 36.6 33.8 22.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CT Gel, Clindamycin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CT Gel, Tretinoin Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CT Gel, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CT Gel Clindamycin Gel Tretinoin Gel Vehicle Gel
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CT Gel Clindamycin Gel Tretinoin Gel Vehicle Gel
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/476 (0.21%)   1/467 (0.21%)   3/464 (0.65%)   1/242 (0.41%) 
Gastrointestinal disorders         
Abdominal pain  1  0/476 (0.00%)  1/467 (0.21%)  0/464 (0.00%)  0/242 (0.00%) 
Infections and infestations         
Bronchitis  1  0/476 (0.00%)  0/467 (0.00%)  0/464 (0.00%)  1/242 (0.41%) 
Infectious mononucleosis  1  1/476 (0.21%)  0/467 (0.00%)  0/464 (0.00%)  0/242 (0.00%) 
Injury, poisoning and procedural complications         
Concussion  1  0/476 (0.00%)  0/467 (0.00%)  1/464 (0.22%)  0/242 (0.00%) 
Psychiatric disorders         
Suicide attempt  1  0/476 (0.00%)  0/467 (0.00%)  1/464 (0.22%)  0/242 (0.00%) 
Reproductive system and breast disorders         
Ovarian cyst  1  0/476 (0.00%)  0/467 (0.00%)  1/464 (0.22%)  0/242 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CT Gel Clindamycin Gel Tretinoin Gel Vehicle Gel
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   27/476 (5.67%)   34/467 (7.28%)   27/464 (5.82%)   18/242 (7.44%) 
Infections and infestations         
Nasopharyngitis  1  27/476 (5.67%)  34/467 (7.28%)  27/464 (5.82%)  18/242 (7.44%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
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.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00689117     History of Changes
Other Study ID Numbers: 114681
W0265-03 ( Other Identifier: Stiefel )
First Submitted: May 24, 2008
First Posted: June 3, 2008
Results First Submitted: November 2, 2010
Results First Posted: December 2, 2010
Last Update Posted: May 30, 2017