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

Phase 2SuspendedNCT01990326

Topokine Therapeutics, Inc.27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Excess Submental Fat ("Double Chin")

Interventions

XAF5 GelDRUG

Placebo GelDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Frequency of adverse events

Time frame: From Day 1 to Day 57

Data from ClinicalTrials.gov

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