Phase 2 Study of XAF5 (XOPH5) Ointment for Reduction of Excess Eyelid Fat (Steatoblepharon)

Phase 2

Completed

• Conditions: Lower Eyelid Steatoblepharon (Excess Eyelid Fat)
• Interventions: Drug: Placebo; Drug: XOPH5 Ointment

• Registration Number: NCT02230761
• Lead Sponsor: Topokine Therapeutics, Inc.

Brief Summary

This study will test whether XAF5 (XOPH5) ointment, applied once daily to the lower eyelids for 10 weeks, reduces the prominence of lower eyelid fat in adults with moderate to severe steatoblepharon (excess eyelid fat).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-28
• Study Start: 2014-09
• Study First Submitted QC: 2014-09-02
• Study First Posted: 2014-09-03
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2015-11-19
• Status Verified: 2015-12
• Results First Submitted QC: 2016-01-09
• Last Update Submitted: 2016-01-09
• Results First Posted: 2016-02-08
• Last Update Posted: 2016-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Ointment	Placebo	Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.
XOPH5 Ointment	XOPH5 Ointment	XOPH5 Ointment is the investigational drug to be studied.

Primary Outcome Measures

Name	Time	Method
Lower Eyelid Steatoblepharon Severity (LESS) Score--Clinician-Reported	11 weeks	Photonumeric scale, range 0-4, 0 is absence of steatoblepharon, 4 is very severe steatoblepharon.

Trial Locations

Locations (1)

Topokine Therapeutics Clinical Study Centers; 🇺🇸 Boston, Massachusetts, United States