Safety and Feasibility Study of XAF5 Gel for Reduction of... | NCT01990326

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

NCT01990326

Sponsor

Topokine Therapeutics, Inc.

Status

Suspended

Last Update Posted

Feb 29, 2016Estimated

Enrollment

27Actual

Phase

Phase 2

Conditions

Excess Submental Fat ("Double Chin")

Interventions

XAF5 Gel
Placebo Gel

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Feasibility cohorts competed. Efficacy cohort not initiated for business reasons

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Jun 2014Actual

Completion Date

Not provided

First Submitted Date

Nov 1, 2013

First Submission Date that Met QC Criteria

Nov 15, 2013

First Posted Date

Nov 21, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2016

Last Update Posted Date

Feb 29, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
XAF5 Gel	Experimental	The patient will apply XAF5 Gel to the skin of the submental area once a night.	Drug: XAF5 Gel
Placebo Gel	Placebo Comparator	The patient will apply a Placebo Gel to the skin of the submental area once a night.	Drug: Placebo Gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
XAF5 Gel	Drug		XAF5 Gel
Placebo Gel

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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided