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
| Name | Class |
|---|---|
| Allergan | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will determine the cumulative irritation potential and sensitization potential of dapsone gel and vehicle after repeat applications on the skin of healthy volunteers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapsone Gel Subset 1 | Experimental | Dapsone gel, dapsone gel vehicle and controls applied to the skin by separate occlusive patches every 24 hours for 21 days followed by a 10 to 17 day rest period then one application each of dapsone gel and dapsone gel vehicle by patch for 48-hours. |
|
| Dapsone Gel Subset 2 | Experimental | Dapsone gel, dapsone gel vehicle and negative control applied to the skin by separate occlusive patches every 48 to 72 hours for 21 days followed by a 10 to 17 day rest period then one application each of dapsone gel and dapsone gel vehicle by patch for 48-hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dapsone gel | Drug | Patches containing dapsone gel will be applied to the skin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Cumulative Irritation Index During Induction Phase | 21 Days | |
| Incidence of Sensitization Reactions During Challenge Phase | 6 Weeks |
Not provided
Not provided
Inclusion Criteria:
-Healthy adults.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fair Lawn | New Jersey | United States |
Not provided
| ID | Term |
|---|---|
| D012967 | Sodium Dodecyl Sulfate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007851 | Dodecanol |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| dapsone gel vehicle | Drug | Patches containing dapsone gel vehicle will be applied to the skin. |
|
| sodium lauryl sulfate | Drug | Patches containing sodium lauryl sulfate (Positive Control) will be applied to the skin. |
|
| Normal saline | Drug | Patches containing normal saline (Negative Control) will be applied to the skin. |
|
| D000476 |
| Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D008055 | Lipids |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |