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

Topokine Therapeutics, Inc.90 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Lower Eyelid Steatoblepharon (Excess Eyelid Fat)

Interventions

XOPH5 OintmentDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria (abbreviated): * Moderate to severe lower eyelid steatoblepharon (LESS score of 2-4 bilaterally) * Men and women 40-70 years old * Healthy facial skin * Must understand and provide informed consent Exclusion Criteria (abbreviated): * Best corrected visual acuity worse than 20/40 in either eye * Regular use of ophthalmic medication in either eye * Planned use of contact lenses during the study * Any history of lower eyelid surgery

Locations (1)

Topokine Therapeutics Clinical Study Centers

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Lower Eyelid Steatoblepharon Severity (LESS) Score--Clinician-Reported

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

Time frame: 11 weeks

Data from ClinicalTrials.gov

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