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

Phase 2

Suspended

• Conditions: Excess Submental Fat ("Double Chin")
• Interventions: Drug: XAF5 Gel; Drug: Placebo Gel

• Registration Number: NCT01990326
• Lead Sponsor: Topokine Therapeutics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-01
• Study First Submitted QC: 2013-11-15
• Study First Posted: 2013-11-21
• Primary Completion: 2014-06
• Status Verified: 2014-07
• Last Update Submitted: 2016-02-26
• Last Update Posted: 2016-02-29

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
XAF5 Gel	XAF5 Gel	The patient will apply XAF5 Gel to the skin of the submental area once a night.
Placebo Gel	Placebo Gel	The patient will apply a Placebo Gel to the skin of the submental area once a night.

Primary Outcome Measures

Name	Time	Method
Frequency of adverse events	From Day 1 to Day 57