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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 incisional wounds
This is primarily a safety study to evaluate the safety of AIV001 when administered near incisional wounds. A unique model was used to assess incisional scarring, safety and biomarker assessments. Women electing to have the abdominoplasty procedure were enrolled in the study and abdominal incisions were generated on the abdominal skin. Up to 10 incisions were made on abdominal skn and treated as assigned. And data collection was conducted up to day 49 when the subjects were exited from the study and the abdominoplasty procedure performed. Exploratory efficacy measures were collected and pharmacokinetic profiles determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.033% versus Vehicle | Experimental | One side of the subject will receive 0.033% AIV001 and the other side of the subject will receive vehicle. |
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| 0.1% versus Vehicle | Experimental | One side of the subject will receive 0.1% AIV001 and the other side of the subject will receive vehicle. |
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| 0.3% versus Vehicle | Experimental | One side of the subject will receive 0.3% AIV001 and the other side of the subject will receive vehicle. |
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| 1% versus Vehicle | Experimental | One side of the subject will receive 1% AIV001 and the other side of the subject will receive vehicle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIV001 | Drug | Intradermal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Local and systemic adverse events | Day 1 through Day 49 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy using Patient and Observer Scar Assessment Scale (6 parameters, 1 normal to 10 worst imaginable) | Evaluation of the healing of the wounds | Day 7 through 49 |
| Modified Vancouver Scar Scale (4 parameters, 0 = normal to 3 or 4 = severe) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Milbauer, MD | Novella Clinical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaufman and Davis Plastic Surgery | Folsom | California | 95630 | United States | ||
| Cosmetic Laser Dermatology |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D000072836 | Surgical Wound |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Randomized, double-blind, vehicle-controlled, dose-escalation
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Treating investigator will administer the study medication. Evaluating Investigator will perform the safety and efficacy evaluations.
Evaluation of the healing wounds
| Day 7 through 49 |
| 100 mm Visual Analogue Scale (0 = normal to 10 = poor scar) | Evaluation of healing wounds | Day 7 through 49 |
| San Diego |
| California |
| 92121 |
| United States |