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

Excess Submental Fat (Double Chin) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01990326
• Other study ID #: XAF5 B1
• Status: Suspended
• Phase: Phase 2
• First received: November 1, 2013
• Last updated: February 26, 2016
• Start date: November 2013

Study information

• Verified date: July 2014
• Source: Topokine Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 27
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Excess Submental Fat (Double Chin)

Intervention

Drug:
• XAF5 Gel

• Placebo Gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Topokine Therapeutics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of adverse events		From Day 1 to Day 57	No