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

Topokine Therapeutics

Status and phase: Suspended; Phase 2

Conditions: Excess Submental Fat ("Double Chin")

Treatments: Drug: XAF5 Gel; Drug: Placebo Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01990326

XAF5 B1

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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27 participants in 2 patient groups, including a placebo group

XAF5 Gel

Experimental group

Description:

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

Treatment:

Drug: XAF5 Gel

Placebo Gel

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Gel