Safety and Feasibility Study of XAF5 Gel for Reduction of Submental Fat

A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of XAF5 Gel for Reduction of Submental Fat

This study will test the effects of XAF5 Gel (applied to skin each night for 6 weeks) on excess submental fat, also known as double chin. The study will also assess the safety and tolerability of XAF5 Gel.

Inclusion Criteria (paraphrased):

• Adult men and women
• Must understand and provide informed consent
• Moderate submental fat (as determined by the clinician)
• No laxity (looseness) or minimal laxity of submental skin
• Healthy skin upon which a skin reaction would be visible

Exclusion Criteria (paraphrased):

• A clinically significant health problem or recent illness
• A clinically significant abnormal result on physical exam or laboratory tests
• Neck or facial hair that would interfere with applying the study drug to submental skin
• Clinically significant skin disease
• Body Mass Index (BMI) >= 40
• Plan to begin a diet or weight loss regimen during the study