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This randomized, placebo-controlled, double-masked, Phase 2b/Phase 3 study will assess the efficacy of two different concentrations of XAF5 Ointment for reduction of lower lid steatoblepharon (undereye bags).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XAF5 (concentration A: 0.1%) | Experimental | Participants will apply XAF5 Ointment (concentration A: 0.1%) to the lower eyelids once daily. |
|
| XAF5 (concentration B: 0.035%) | Experimental | Participants will apply XAF5 Ointment (concentration B: 0.035%) to the lower eyelids once daily. |
|
| Placebo | Placebo Comparator | Participants will apply Placebo Ointment to the lower eyelids once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XAF5 (concentration A: 0.1%) | Drug |
| ||
| XAF5 (concentration B: 0.035%) |
| Measure | Description | Time Frame |
|---|---|---|
| LESS score (Clinician-Reported) | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Roth, Ph.D. | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Wirta, MD, Inc. | Newport Beach | California | United States | |||
| OC Clinical Trials |
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| Drug |
|
| Matching placebo | Drug |
|
| Santa Ana |
| California |
| United States |
| Danbury Eye Physicians | Danbury | Connecticut | United States |
| Opthalmic Consultants of Boston | Boston | Massachusetts | United States |
| South Shore Eye Care, Inc. | Wantagh | New York | United States |
| Cincinatti Eye Institute | Cincinnati | Ohio | United States |