Trial · NCT00689117
A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel
NCT00689117, Phase 3, Completed, Stiefel, a GSK Company; results first posted 2010-12-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel. Trials, record NCT00689117. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00689117
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel
- NCT number
- NCT00689117
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,649 participants, actual
- Lead sponsor
- Stiefel, a GSK Company
- Conditions
- Acne Vulgaris, Acne
- Interventions
- CT Gel, Clindamycin Gel (clindamycin ), Tretinoin Gel (tretinoin), Vehicle Gel
- First posted
- 2008-06-03
- Last updated
- 2017-05-30
- Results first posted
- 2010-12-02
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| 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 | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | Baseline, Week 12 | Intent-to-Treat (ITT) Population: all participants who were randomized to and received at least one application of study product. | lesions | MEAN |
| 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 | Baseline, Week 12 | ITT Population | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12 | Baseline, Week 12 | ITT Population | percent change | MEAN |
| SECONDARY | The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12 | Week 12 | ITT Population | participants | NUMBER |
| SECONDARY | The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12 | Week 12 | ITT Population | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | CT Gel | Inflammatory Lesion Counts | -15.5 | Standard Deviation 10.33 | lesions |
| Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | Clindamycin Gel | Inflammatory Lesion Counts | -14.5 | Standard Deviation 9.37 | lesions |
| Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | Tretinoin Gel | Inflammatory Lesion Counts | -13.9 | Standard Deviation 11.05 | lesions |
| Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | Vehicle Gel | Inflammatory Lesion Counts | -11.1 | Standard Deviation 11.70 | lesions |
| Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | CT Gel | Non-Inflammatory Lesion Counts | -23.2 | Standard Deviation 20.41 | lesions |
| Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | Clindamycin Gel | Non-Inflammatory Lesion Counts | -19.5 | Standard Deviation 19.72 | lesions |
| Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | Tretinoin Gel | Non-Inflammatory Lesion Counts | -22.1 | Standard Deviation 21.75 | lesions |
| Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | Vehicle Gel | Non-Inflammatory Lesion Counts | -17.0 | Standard Deviation 20.58 | lesions |
| Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | CT Gel | Total Lesion Counts | -38.7 | Standard Deviation 26.80 | lesions |
| Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | Clindamycin Gel | Total Lesion Counts | -34.0 | Standard Deviation 25.16 | lesions |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CT Gel | 476 | |
| Overall Study | STARTED | Clindamycin Gel | 467 | |
| Overall Study | STARTED | Tretinoin Gel | 464 | |
| Overall Study | STARTED | Vehicle Gel | 242 | |
| Overall Study | COMPLETED | CT Gel | 414 | |
| Overall Study | COMPLETED | Clindamycin Gel | 416 | |
| Overall Study | COMPLETED | Tretinoin Gel | 405 | |
| Overall Study | COMPLETED | Vehicle Gel | 211 | |
| Overall Study | NOT COMPLETED | CT Gel | 62 | |
| Overall Study | NOT COMPLETED | Clindamycin Gel | 51 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | CT Gel | 27 | 476 | |
| other | Nasopharyngitis | Infections and infestations | Clindamycin Gel | 34 | 467 | |
| other | Nasopharyngitis | Infections and infestations | Tretinoin Gel | 27 | 464 | |
| other | Nasopharyngitis | Infections and infestations | Vehicle Gel | 18 | 242 | |
| serious | Abdominal pain | Gastrointestinal disorders | CT Gel | 0 | 476 | |
| serious | Abdominal pain | Gastrointestinal disorders | Clindamycin Gel | 1 | 467 | |
| serious | Abdominal pain | Gastrointestinal disorders | Tretinoin Gel | 0 | 464 | |
| serious | Abdominal pain | Gastrointestinal disorders | Vehicle Gel | 0 | 242 | |
| serious | Bronchitis | Infections and infestations | CT Gel | 0 | 476 | |
| serious | Bronchitis | Infections and infestations | Clindamycin Gel | 0 | 467 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CT Gel | ||
| Total, all-cause mortality | Clindamycin Gel | ||
| Total, all-cause mortality | Tretinoin Gel | ||
| Total, all-cause mortality | Vehicle Gel | ||
| Total, other adverse events | CT Gel | 27 | 476 |
| Total, other adverse events | Clindamycin Gel | 34 | 467 |
| Total, other adverse events | Tretinoin Gel | 27 | 464 |
| Total, other adverse events | Vehicle Gel | 18 | 242 |
| Total, serious adverse events | CT Gel | 1 | 476 |
| Total, serious adverse events | Clindamycin Gel | 1 | 467 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00689117
GET https://conductscience.org/api/trials/v1/NCT00689117/results?page=2