Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This Phase II study is to evaluate the efficacy of SR-T100 gel with 2.3% of SM in Solanum undatum plant extract in patient with Actinic Keratosis (AK).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo, gel | Placebo Comparator | placebo comparator |
|
| SR-T100 with 2.3% of SM, gel | Active Comparator | 2.3% of SM in Solanum undatum plant extract |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vehicle gel | Drug | placebo |
| |
| SR-T100 with 2.3% of SM |
| Measure | Description | Time Frame |
|---|---|---|
| Total clearance rate: | The proportion of patients achieving total clearance of AK lesions in the treatment area (in total of 25cm2 area) at 8-week post-EOT visit (scheduled at Week 24 visit) . | 8-week post-EOT visit (scheduled at Week 24 visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Partial clearance rate | The proportion of patients achieving ≥ 75% total clinically assessed AK lesion counts out of all target lesions in the treatment area (in total of 25cm2 area) at the post-EOT visit (8 weeks after EOT visit). | 24 week |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contour Dermatology & Cosmetic Surgery Center | Rancho Mirage | California | 92270 | United States | ||
| IMMUNOe International Research Centers |
Not provided
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C562184 | SR-T100 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
2.3% of SM in Solanum undatum plant extract |
|
|
| Longmont |
| Colorado |
| 80501 |
| United States |
| Atlantic Clinical Research Collaborative | West Palm Beach | Florida | 33406 | United States |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | United States |
| Suzanne Bruce and Associates,P.A. The Center for Skin Research | Katy | Texas | 77056 | United States |
| Pflugerville Dermatology Clinical Research | Pflugerville | Texas | 78660 | United States |
| The Education & Research Foundation, Inc | Lynchburg | Virginia | 24501 | United States |
| Premier Clinical Research | Spokane | Washington | 99204 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |