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This 4-arm Phase 2 vehicle-controlled study is designed to assess the safety and efficacy of PDI-320, and the individual components, in adult subjects with rosacea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDI-320 | Experimental | Foam, twice daily for up to 12 weeks |
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| PDI-320 Monad #1 | Experimental | Foam, twice daily for up to 12 weeks |
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| PDI-320 Monad #2 | Experimental | Foam, twice daily for up to 12 weeks |
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| Vehicle | Placebo Comparator | Foam, twice daily for up to 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDI-320 | Drug |
| ||
| PDI-320 Monad #1 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment "Success Rate" based on change in Investigator's Global Assessment (IGA) | IGA Score Success Rate is defined as the percentage of subjects who achieve "Clear" (score = 0) or "Almost Clear" (score = 1) and have at least a 2-grade improvement on the IGA score at the End of Treatment. IGA score is used to evaluate the overall severity of rosacea using a 5-point scale from 0 (clear) to 4 (severe). | Baseline and End of Treatment (up to 12 weeks) |
| Absolute change in inflammatory lesion count | Inflammatory lesions include papules and pustules on the face, and are counted by study personnel. | Baseline and End of Treatment (up to 12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment "Success Rate" based on change in IGA (interim time points) | IGA Score Success Rate is the same as defined in the Primary Outcome Measures. | Baseline, Week 4 and Week 8 |
| Absolute change in inflammatory lesion count (interim time points) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Syd Dromgoole, PhD | Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Therapeutics Clinical Research | San Diego | California | United States | |||
| Academic Dermatology Associates |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| PDI-320 Monad #2 | Drug |
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| Vehicle | Drug |
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Inflammatory lesions include papules and pustules on the face, and are counted by study personnel.
| Baseline, Week 4 and Week 8 |
| Change in erythema severity | The investigator will assess the erythema (skin redness) on the entire face, using a grading scale from 0 (none) to 4 (very severe) | Baseline and End of Treatment (up to 12 weeks) |
| Change in telangiectasia severity | The investigator will assess telangiectasia (small dilated blood vessels near the surface of the skin) on the face, using a grading scale of 0 (none) to 3 (severe). | Baseline and End of Treatment (up to 12 weeks) |
| Albuquerque |
| New Mexico |
| United States |