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

NCT ID: NCT01990326

Last Updated: 2016-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Brief Summary

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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

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Conditions

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Excess Submental Fat ("Double Chin")

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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XAF5 Gel

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

Group Type EXPERIMENTAL

XAF5 Gel

Intervention Type DRUG

Placebo Gel

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

Group Type PLACEBO_COMPARATOR

Placebo Gel

Intervention Type DRUG

Interventions

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XAF5 Gel

Intervention Type DRUG

Placebo Gel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Topokine Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael S Singer, M.D., Ph.D.

Role: STUDY_DIRECTOR

Topokine Therapeutics

Other Identifiers

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XAF5 B1

Identifier Type: -

Identifier Source: org_study_id