A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel
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.
Timeline
- Start
- 2008-04
- Primary completion
- 2009-04
- Completion
- 2009-05
Outcome
Mixed primary results
registry analysis (superiority or other test); CT Gel vs Clindamycin Gel; p = 0.063; Ranked ANCOVA; note: Inflammatory lesion count NCT00689117 ↗
registry MEAN CT Gel: Inflammatory Lesion Counts: -15.5 (Standard Deviation 10.33) lesions NCT00689117 ↗
registry MEAN Clindamycin Gel: Inflammatory Lesion Counts: -14.5 (Standard Deviation 9.37) lesions NCT00689117 ↗
registry analysis (superiority or other test); CT Gel vs Clindamycin Gel; p = 0.004; Ranked ANCOVA; note: Non-inflammatory lesion count NCT00689117 ↗
registry MEAN CT Gel: Non-Inflammatory Lesion Counts: -23.2 (Standard Deviation 20.41) lesions NCT00689117 ↗
registry MEAN Clindamycin Gel: Non-Inflammatory Lesion Counts: -19.5 (Standard Deviation 19.72) lesions NCT00689117 ↗
registry analysis (superiority or other test); CT Gel vs Clindamycin Gel; p = 0.001; Cochran-Mantel-Haenszel; note: Data based on Data on File documenting FDA reanalysis request NCT00689117 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clindamycin | Unknown | 1 % | Topical |
| Subject | Tretinoin | Unknown | 0.025 % | Topical |