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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2, Randomized, Double-masked, Placebo-controlled Study of XOPH5 Ointment for Reduction of Lower Lid Steatoblepharon

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 Summary:
Sponsor: Topokine Therapeutics, Inc.

Current Primary Outcome: Lower Eyelid Steatoblepharon Severity (LESS) Score--Clinician-Reported [ Time Frame: 11 weeks ]

Photonumeric scale, range 0-4, 0 is absence of steatoblepharon, 4 is very severe steatoblepharon.


Original Primary Outcome: Lower Eyelid Steatoblepharon Severity (LESS) score [ Time Frame: 11 weeks ]

Current Secondary Outcome:

Original Secondary Outcome: Safety (frequency of adverse events, by type) [ Time Frame: 11 weeks ]

Information By: Topokine Therapeutics, Inc.

Dates:
Date Received: August 28, 2014
Date Started: September 2014
Date Completion:
Last Updated: January 9, 2016
Last Verified: December 2015