Trial Outcomes & Findings for A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel (NCT NCT00689117)
NCT ID: NCT00689117
Last Updated: 2017-05-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1649 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2017-05-30
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
476
|
467
|
464
|
242
|
|
Overall Study
COMPLETED
|
414
|
416
|
405
|
211
|
|
Overall Study
NOT COMPLETED
|
62
|
51
|
59
|
31
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
0
|
5
|
0
|
|
Overall Study
Lost to Follow-up
|
26
|
19
|
17
|
11
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
2
|
2
|
|
Overall Study
Non-Compliance with Study Treatment
|
3
|
3
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
19
|
18
|
26
|
13
|
|
Overall Study
Unable to Comply with Visit Schedule
|
0
|
0
|
1
|
1
|
|
Overall Study
Inclusion/Exclusion Criteria Not Met
|
1
|
2
|
0
|
0
|
|
Overall Study
Non-compliance with Treatment Regimen
|
0
|
1
|
0
|
0
|
|
Overall Study
Change/Discontinuation of Birth Control
|
1
|
1
|
1
|
0
|
|
Overall Study
Use of Prohibitive Medication
|
2
|
1
|
3
|
0
|
|
Overall Study
Pregnancy
|
0
|
2
|
0
|
2
|
|
Overall Study
Incarceration
|
2
|
0
|
0
|
0
|
|
Overall Study
Fear of Birth Defects
|
0
|
0
|
1
|
0
|
|
Overall Study
Transportation
|
1
|
0
|
0
|
0
|
|
Overall Study
Patient Withdrew from Study
|
0
|
0
|
0
|
1
|
|
Overall Study
Personal Reason
|
0
|
1
|
0
|
0
|
|
Overall Study
Dispensing Error
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel
Baseline characteristics by cohort
| Measure |
CT Gel
n=476 Participants
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
n=467 Participants
Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
|
Tretinoin Gel
n=464 Participants
Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
|
Vehicle Gel
n=242 Participants
Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
|
Total
n=1649 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
20.8 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
20.2 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
20.2 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
20.6 years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
20.4 years
STANDARD_DEVIATION 8.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
269 Participants
n=5 Participants
|
266 Participants
n=7 Participants
|
264 Participants
n=5 Participants
|
153 Participants
n=4 Participants
|
952 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
207 Participants
n=5 Participants
|
201 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
697 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
3 participants
n=4 Participants
|
15 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
11 participants
n=5 Participants
|
5 participants
n=4 Participants
|
32 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
94 participants
n=5 Participants
|
85 participants
n=7 Participants
|
103 participants
n=5 Participants
|
51 participants
n=4 Participants
|
333 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
12 participants
n=5 Participants
|
16 participants
n=7 Participants
|
19 participants
n=5 Participants
|
5 participants
n=4 Participants
|
52 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Other Pacific Islander
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
358 participants
n=5 Participants
|
349 participants
n=7 Participants
|
324 participants
n=5 Participants
|
176 participants
n=4 Participants
|
1207 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-Treat (ITT) Population: all participants who were randomized to and received at least one application of study product.
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.
Outcome measures
| Measure |
CT Gel
n=476 Participants
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
n=467 Participants
Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
|
Tretinoin Gel
n=464 Participants
Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
|
Vehicle Gel
n=242 Participants
Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
|
|---|---|---|---|---|
|
Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study)
Inflammatory Lesion Counts
|
-15.5 lesions
Standard Deviation 10.33
|
-14.5 lesions
Standard Deviation 9.37
|
-13.9 lesions
Standard Deviation 11.05
|
-11.1 lesions
Standard Deviation 11.70
|
|
Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study)
Non-Inflammatory Lesion Counts
|
-23.2 lesions
Standard Deviation 20.41
|
-19.5 lesions
Standard Deviation 19.72
|
-22.1 lesions
Standard Deviation 21.75
|
-17.0 lesions
Standard Deviation 20.58
|
|
Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study)
Total Lesion Counts
|
-38.7 lesions
Standard Deviation 26.80
|
-34.0 lesions
Standard Deviation 25.16
|
-36.0 lesions
Standard Deviation 28.26
|
-28.1 lesions
Standard Deviation 27.26
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: ITT Population
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.
Outcome measures
| Measure |
CT Gel
n=476 Participants
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
n=467 Participants
Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
|
Tretinoin Gel
n=464 Participants
Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
|
Vehicle Gel
n=242 Participants
Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
|
|---|---|---|---|---|
|
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
|
36.3 percentage of participants
|
26.6 percentage of participants
|
26.1 percentage of participants
|
20.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT Population
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.
Outcome measures
| Measure |
CT Gel
n=476 Participants
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
n=467 Participants
Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
|
Tretinoin Gel
n=464 Participants
Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
|
Vehicle Gel
n=242 Participants
Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
|
|---|---|---|---|---|
|
Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12
Total Lesions
|
-55.0 percent change
Standard Deviation 30.47
|
-49.0 percent change
Standard Deviation 30.08
|
-50.6 percent change
Standard Deviation 34.82
|
-39.1 percent change
Standard Deviation 36.48
|
|
Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12
Inflammatory Lesions
|
-60.5 percent change
Standard Deviation 36.21
|
-56.6 percent change
Standard Deviation 44.99
|
-54.5 percent change
Standard Deviation 39.19
|
-43.3 percent change
Standard Deviation 44.9
|
|
Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12
Non-Inflammatory Lesions
|
-51.1 percent change
Standard Deviation 33.02
|
-42.9 percent change
Standard Deviation 36.6
|
-47.3 percent change
Standard Deviation 43.5
|
-36.0 percent change
Standard Deviation 39.14
|
SECONDARY outcome
Timeframe: Week 12Population: ITT Population
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.
Outcome measures
| Measure |
CT Gel
n=476 Participants
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
n=467 Participants
Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
|
Tretinoin Gel
n=464 Participants
Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
|
Vehicle Gel
n=242 Participants
Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
|
|---|---|---|---|---|
|
The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12
|
62 participants
|
60 participants
|
62 participants
|
50 participants
|
SECONDARY outcome
Timeframe: Week 12Population: ITT Population
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.
Outcome measures
| Measure |
CT Gel
n=476 Participants
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
n=467 Participants
Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
|
Tretinoin Gel
n=464 Participants
Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
|
Vehicle Gel
n=242 Participants
Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
|
|---|---|---|---|---|
|
The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12
|
43.1 percentage of participants
|
36.6 percentage of participants
|
33.8 percentage of participants
|
22.7 percentage of participants
|
Adverse Events
CT Gel
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Clindamycin Gel
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
Tretinoin Gel
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Vehicle Gel
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CT Gel
n=476 participants at risk
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
n=467 participants at risk
Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
|
Tretinoin Gel
n=464 participants at risk
Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
|
Vehicle Gel
n=242 participants at risk
Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/476
|
0.21%
1/467
|
0.00%
0/464
|
0.00%
0/242
|
|
Infections and infestations
Bronchitis
|
0.00%
0/476
|
0.00%
0/467
|
0.00%
0/464
|
0.41%
1/242
|
|
Infections and infestations
Infectious mononucleosis
|
0.21%
1/476
|
0.00%
0/467
|
0.00%
0/464
|
0.00%
0/242
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/476
|
0.00%
0/467
|
0.22%
1/464
|
0.00%
0/242
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/476
|
0.00%
0/467
|
0.22%
1/464
|
0.00%
0/242
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/476
|
0.00%
0/467
|
0.22%
1/464
|
0.00%
0/242
|
Other adverse events
| Measure |
CT Gel
n=476 participants at risk
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
n=467 participants at risk
Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
|
Tretinoin Gel
n=464 participants at risk
Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
|
Vehicle Gel
n=242 participants at risk
Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.7%
27/476
|
7.3%
34/467
|
5.8%
27/464
|
7.4%
18/242
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER