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
Not provided
Not provided
Not provided
This trial is testing a drug to see if multiple injections to the undereye bags of selected patients decreases the volume of the eyebags as compared to placebo. Subjects will be randomized to receive either one of two doses of POLAT-001 or placebo. POLAT-001 will be injected into the eyebags at three of the visits. Each subject will attend 7-10 clinic visits over 98 to 140 days total to assess efficacy and safety.
This trial is a proof-of-concept trial and is testing a drug to see if multiple injections to the undereye bags of selected patients decreases the volume of the eyebags as compared to placebo. Subjects will be randomized to receive either one of two doses of POLAT-001 (1 mg/mL or 2 mg/mL) or placebo (normal saline). POLAT-001 will be injected into the eyebags at three of the visits. Each subject will attend 7-10 clinic visits total over 98 to 140 days to assess efficacy and safety. Subjects assigned to placebo will crossover to receive active treatment. Efficacy will be determined using questionnaires and photography. Safety will be assessed by subject-reported events and investigator observations of the subjects.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (Normal Saline) | Placebo Comparator | Subjects will be randomized 1:5 (1 Placebo subject to 5 receiving active treatment) to receive placebo (Normal Saline) with a volume of 120 microliters injection. |
|
| POLAT-001 | Experimental | Subjects will be randomized 1:5 (1 Placebo subject to 5 receiving active treatment) to receive POLAT-001 with a volume of 120 microliters injection, at either 1 mg/mL or 2 mg/mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POLAT-001 | Drug | Subjects will be randomized to receive three injections per under eyebag, either 1 mg/mL or 2 mg/mL and 120 microliter volume, at each of three treatment visits. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change of photonumeric volume of eyebags in the POLAT-001 treated and placebo dose groups as measured by a 3D photography system | Baseline to 28 days after the last treatment cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of eyebags in the POLAT-001 treated and placebo dose groups with at least 10% reduction in photonumeric volume as measured by a 3D photography system | Baseline to 28 days after the last treatment | |
| Proportion of eyebags in the POLAT-001 treated and placebo dose groups with at least 30% reduction in photonumeric volume as measured by a 3D photography system |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Associates, Inc. | Newport Beach | California | 92663 | United States | ||
| Skin Associates of South Florida |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
The participant, PI, sponsor will be masked until visit 5 at which time unmasking will occur to whether placebo or treatment so that placebo subjects can cross over to receive active treatment.
| Placebo | Drug | Subjects will be randomized to receive three injections of 120 microliters total of Normal Saline per under eyebag at each of three treatment visits. |
|
|
| Baseline to 28 days after the last treatment cycle |
| Mean change in photonumeric volume of eyebags between the POLAT-001 treated high and low dose groups as measured by a 3D photography system | Baseline to 28 days after the last treatment cycle |
| Coral Gables |
| Florida |
| 33146 |
| United States |
| Austin Institute for Clinical Research | Pflugerville | Texas | 78660 | United States |