Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00689117 | A Clinical Study to Evaluate the Safety and Effectiveness of an Investigational Product Called CT Gel | PHASE3 | COMPLETED | 1,649 | — | — | Apr 1, 2008 | May 1, 2009 | May 30, 2017 | 32 | United States, Belize +1 |
| NCT01929278 | W0265-103: A Single-Center, Evaluator-Blinded, Randomized, Placebo Controlled, Phase 1 Clinical Trial Evaluating The Phototoxic Potential Of Topically Applied Clindamycin 1.0% - Tretinoin 0.025% Gel (Ct Gel) In Healthy Volunteers | PHASE1 | COMPLETED | 37 | — | — | Dec 8, 2008 | Dec 19, 2008 | Jul 18, 2017 | - | — |
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.
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.
In cases where the patch area is larger than the irradiated area, only the irradiated areas will be scored unless reactions outside the irradiated area exhibit unusual responses. Scores represent the presence of clinically significant effects on at least 25% of the test site. Questionable, barely perceptible, or minimal reactions involving less than 25% of the test site will not be considered significant.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | CT Gel |
| 2 | ACTIVE_COMPARATOR | Clindamycin Gel (clindamycin) |
| 3 | ACTIVE_COMPARATOR | Tretinoin Gel (tretinoin) |
| 4 | PLACEBO_COMPARATOR | Vehicle Gel |
| CT Gel patch | EXPERIMENTAL | CT Gel is a reformulation of VELAC Gel that contains the same active ingredients (clindamycin 1% and tretinoin 0.025%) in a modified vehicle. The test article was placed on a separate occlusive patch at volumes of 200 µL per patch. |
| Vehicle gel patch | PLACEBO_COMPARATOR | The test article was placed on a separate occlusive patch at volumes of 200 µL per patch. |
| Blank patch | EXPERIMENTAL | Blank patches did not contain CT Gel or vehicle gel. |
| Name | Type | Description |
|---|---|---|
| CT Gel | DRUG | Topical gel consisting of clindamycin 1% and tretinoin 0.025%, applied once daily in the evening for 12 weeks |
| Clindamycin Gel (clindamycin ) | DRUG | Clindamycin 1% gel applied topically once daily in the evening for 12 weeks |
| Tretinoin Gel (tretinoin) | DRUG | Tretinoin 0.025% gel applied topically once daily in the evening for 12 weeks |
| Vehicle Gel | DRUG | Topical gel without clindamycin or tretinoin applied topically once daily in the evening for 12 weeks |
| CT Gel (clindamycin 1% and tretinoin 0.025%) | DRUG | Three CT Gel patches were concurrently applied to designated test sites by trained technicians and held in place with hypoallergenic tape. Patches were prepared no longer than 30 minutes prior to application to study subjects. A minimum distance of ¾ of an inch from patch pad to patch pad was maintained on a subject's back. Approximately 24 ±1 hours after patch application, test patches were removed by trained technicians. Patch sites were evaluated for signs of inflammation according to procedures. |
| Vehicle gel patch | OTHER | Three vehicle gel patches were concurrently applied to designated test sites by trained technicians and held in place with hypoallergenic tape. Patches were prepared no longer than 30 minutes prior to application to study subjects. A minimum distance of ¾ of an inch from patch pad to patch pad was maintained on a subject's back. Approximately 24 ±1 hours after patch application, test patches were removed by trained technicians. Patch sites were evaluated for signs of inflammation according to procedures. 2. Vehicle gel contained the identical ingredients and packaging as CT Gel but without the active ingredients. All vehicle gel used during the study was from batch ZLU C. |
| Blank patch | OTHER | Three blank patches were concurrently applied to designated test sites by trained technicians and held in place with hypoallergenic tape. Patches were prepared no longer than 30 minutes prior to application to study subjects. A minimum distance of ¾ of an inch from patch pad to patch pad was maintained on a subject's back. Approximately 24 ±1 hours after patch application, test patches were removed by trained technicians. Patch sites were evaluated for signs of inflammation according to procedures. 3. Occlusive patches consisted of a non-woven cotton pad (Webril \[approximately 2 cm x 2 cm\]) covered and secured on all sides by an occlusive hypoallergenic tape (approximately 4 cm x 4 cm). |
Inclusion Criteria: * Male or female 12 years of age or older in good general health * Investigator's Static Global Assessment (ISGA) score of 2 or greater at Baseline Exclusion Criteria: * Any nodulo-cystic lesions at Baseline * Pregnancy or breast feeding * History or presence of regional enter...