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Subjects with a clinical diagnosis of plaque psoriasis with 10% to 20% of body surface area affected will be enrolled in the study.
Approximately 60 subjects with a clinical diagnosis of moderate or severe psoriasis (defined as at least of 10 % - 20% treatable Body Surface Area (BSA) and an Investigator's Global Evaluation (IGE) of 3 or 4 at baseline (moderate or severe) will be enrolled in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDP-118 Low Strength | Experimental | IDP-118 Low Strength |
|
| IDP-118 High Strength | Experimental | IDP-118 High Strength |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDP-118 Low Strength | Drug | 8 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of HPA axis suppression after treatment with investigational drug product and the comparators | To measure the incidence of HPA axis suppression after treatment with investigational drug product and the comparators | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and cutaneous tolerability of the two formulations and the comparators | To evaluate and Local Skin Reactions: Tolerability will be evaluated through assessment of selected local signs and symptoms at the drug-application site: itching, dryness, burning and stinging. In addition the treatment areas will be examined at each visit for significant known drug-related AEs such as skin atrophy, striae, telangiectasia and folliculitis. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate efficacy, defined as reduction of severity of disease in a sample target plaque during the course of the study | The Investigator will assess the target lesion site affected by psoriasis at each visit. Areas affected by psoriasis (at a minimum 10% BSA) are to be treated with study drug | 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd Plott, MD | Medical Monitor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dow Clinical Study Site | Santa Rosa | California | 95403 | United States | ||
| Dow Clinical Study Site |
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| IDP-118 High Strength | Drug | 8 weeks |
|
|
| 8 weeks |
| Clinton Township |
| Michigan |
| 48038 |
| United States |
| Dow Cliincal Study Site | Fort Gratiot | Michigan | 48059 | United States |
| Dow Clinical Study Site | Nashville | Tennessee | 37215 | United States |
| Dow Clinical Study Site | Austin | Texas | 78759 | United States |
| Dow Clinical Study Site | Norfolk | Virginia | 23507 | United States |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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