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Sponsor deprioritization
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To evaluate the safety, efficacy, and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with rosacea.
This is primarily a safety study to evaluate the safety of AIV001 when administered to subjects with rosacea. Exploratory efficacy measures will also be collected as well as pharmacokinetic profiles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - vehicle | Placebo Comparator | Subjects randomized to vehicle will receive vehicle administration to the target area. |
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| Cohort 1 - 0.033% | Active Comparator | Subjects randomized to vehicle will receive AIV001 0.033% administration to the target area. |
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| Cohort 2 - vehicle | Placebo Comparator | Subjects randomized to vehicle will receive vehicle administration to the target area. |
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| Cohort 2 - 0.1% | Active Comparator | Subjects randomized to vehicle will receive AIV001 0.01% administration to the target area. |
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| Cohort 3 - vehicle | Placebo Comparator | Subjects randomized to vehicle will receive vehicle administration to the target area. |
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| Cohort 3 - 0.3% | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIV001 | Drug | intradermal injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Adverse Events | The occurrence of adverse events will be collected and reported using MedDRA to code. Description, start and end dates, and severity will be recorded. | Day 1 through Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy evaluated by the Investigator using the Investigator Global Assessment Scale | Evaluation of rosacea within the treatment area. 0 = clear (No papules and/or pustules; no or residual erythema; no or mild to moderate telangiectasia), 1 = minimal (Rare papules and/or pustules; residual to mild erythema; mild to moderate telangiectasia), 2 = mild (Few papules and/or pustules; mild erythema; mild to moderate telangiectasia), 3 = mild to moderate (Distinct number of papules and/or pustules; mild to moderate erythema; mild to moderate telangiectasia), 4 = moderate (Pronounced number of papules and/or pustules; moderate erythema; mild to moderate telangiectasia), 5 = moderate to severe (Many papules and/or pustules; occasionally with large inflamed lesions; moderate erythema; moderate degree of telangiectasia), and 6 = severe (Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate or severe erythema; moderate or severe telangiectasia). Scores of 0 or 1 are considered success. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell Goldman, MD | West Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cosmetic Laser Dermatology | San Diego | California | 92121 | United States |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Randomized, double-blind, vehicle-controlled, parallel-group, dose-escalation study evaluating study medication versus vehicle in each of 4 sequentially enrolled cohorts
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Study medication will be administered by the Treating Investigator. Safety and efficacy measures will be evaluated by the masked Evaluating Investigator.
Subjects randomized to vehicle will receive AIV001 0.03% administration to the target area.
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| Cohort 4 - vehicle | Placebo Comparator | Subjects randomized to vehicle will receive vehicle administration to the target area. |
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| Cohort 4 - 1% | Active Comparator | Subjects randomized to vehicle will receive AIV001 0.03% administration to the target area. |
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| Vehicle | Drug | intradermal injection |
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| Day 1 through Day 84 |
| Efficacy evaluated by the Investigator by performing Inflammatory Lesion Counts | The number of inflammatory lesions is a static measure of the number of papules or pustules present within the treatment area. | Day 1 through 84 |
| Evaluation of Erythema and Topography using Standardized Photography | Photographs using standardized equipment will be taken and uploaded onto the vendor's server. The vendor will then use proprietary software to measure the amount of redness and the topography of the lesions within the treatment area. | Day 1 through 84 |