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
Not provided
The objectives of this study are to evaluate the therapeutic equivalence and safety of Adapalene Gel 0.3% and Differin® (adapalene gel 0.3%).
The objectives of this study are to evaluate the therapeutic equivalence and safety of Adapalene Gel 0.3% and Differin® (adapalene gel 0.3%) in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapalene Gel 0.3% | Experimental | Adapalene Gel 0.3% (Taro Pharmaceuticals Inc.) |
|
| Differin® | Active Comparator | Differin® (adapalene gel 0.3%) (Galderma Laboratories, LP, US) |
|
| Placebo | Placebo Comparator | Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapalene Gel 0.3% | Drug | Adapalene Gel 0.3% applied to the entire face once daily for 84 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in inflammatory lesion counts | Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts | Week 12 |
| Change in non-inflammatory lesion counts | Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response of success | The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment | Week 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Catawba Research | http://catawbaresearch.com/contact/ | Study Chair |
Not provided
Not provided
| 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 |
|---|---|
| D000068816 | Adapalene |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Differin® | Drug | Differin® applied to the entire face once daily for 84 consecutive days |
|
|
| Placebo | Drug | Placebo (vehicle of the test product) applied to the entire face once daily for 84 consecutive days |
|
|
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |