NCT01990326

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.

Trial Health

20
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
27

participants targeted

Target at below P25 for phase_2

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Last Updated

February 29, 2016

Status Verified

July 1, 2014

Enrollment Period

7 months

First QC Date

November 1, 2013

Last Update Submit

February 26, 2016

Conditions

Excess Submental Fat ("Double Chin")

Outcome Measures

Primary Outcomes (1)

  • Frequency of adverse events

    From Day 1 to Day 57

Study Arms (2)

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

XAF5 GelDRUG
XAF5 Gel
Placebo GelDRUG
Placebo Gel

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Michael S Singer, M.D., Ph.D.

    Topokine Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2013

First Posted

November 21, 2013

Study Start

November 1, 2013

Primary Completion

June 1, 2014

Last Updated

February 29, 2016

Record last verified: 2014-07