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

Status

Suspended

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01990326

Enrollment

Registered

2013-11-21

Start date

2013-11-30

Completion date

Unknown

Last updated

2016-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Excess Submental Fat (Double Chin)

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.

Interventions

DRUGXAF5 Gel

DRUGPlacebo Gel

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Frequency of adverse events	From Day 1 to Day 57

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026