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.

Study Overview

• Status: Suspended
• Conditions: Excess Submental Fat ("Double Chin")
• Intervention / Treatment: Drug: XAF5 Gel; Drug: Placebo Gel

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XAF5 Gel; The patient will apply XAF5 Gel to the skin of the submental area once a night.	Drug: XAF5 Gel
Placebo Comparator: Placebo Gel; The patient will apply a Placebo Gel to the skin of the submental area once a night.	Drug: Placebo Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of adverse events	From Day 1 to Day 57

Collaborators and Investigators

• Sponsor: Topokine Therapeutics, Inc.
• Investigators: Study Director: Michael S Singer, M.D., Ph.D., Topokine Therapeutics

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: November 1, 2013
• First Submitted That Met QC Criteria: November 15, 2013
• First Posted (Estimate): November 21, 2013

Study Record Updates

• Last Update Posted (Estimate): February 29, 2016
• Last Update Submitted That Met QC Criteria: February 26, 2016
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: XAF5 B1