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
Bioequivalence study comparing Tretinoin Cream, 0.1% to RETIN-A®.
A Multi-center, Double-Blind, Randomized, Placebo controlled, Parallel-Group study, comparing TRETINOIN CREAM, 0.1% (TARO PHARMACEUTICALS U.S.A., INC.) to RETIN-A® (TRETINOIN) CREAM, 0.1% (VALEANT) and both active treatments to a Placebo Control in the treatment of Acne Vulgaris
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tretinoin cream 0.1% | Experimental | Once daily at home, to apply the entire affected areas of the face. |
|
| RETIN-A® Cream | Active Comparator | Once daily at home, to apply the entire affected areas of the face. |
|
| Vehicle of the test product | Placebo Comparator | Once daily at home, to apply the entire affected areas of the face. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tretinoin cream 0.1% | Drug | Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demonstration of Bioequivalence | Demonstration of Bioequivalence in Percent change in inflammatory and non-inflammatory lesion counts | 12 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zaidoon A Al-Zubaidy | Catawba Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catawba Research, LLC | Charlotte | North Carolina | 28217 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| RETIN-A® Cream | Drug | RETIN-A® (Tretinoin) Cream (Valeant) |
|
|
| Vehicle of the test product | Drug | Vehicle for Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.) |
|
|
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014212 | Tretinoin |
| ID | Term |
|---|---|
| D014801 | Vitamin A |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
Not provided
Not provided