Phase 2
N=90
Phase 2 Study of XAF5 (XOPH5) Ointment for Reduction of Excess Eyelid Fat (Steatoblepharon)
Lower Eyelid Steatoblepharon (Excess Eyelid Fat)
Bottom Line
View on ClinicalTrials.gov: NCT02230761 ↗Enrolled (actual)
90
Serious AEs
1.1%
Results posted
Feb 2016
Primary outcome: Primary: Lower Eyelid Steatoblepharon Severity (LESS) Score--Clinician-Reported — 27; 6 participants — p=0.020
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- XOPH5 Ointment (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Topokine Therapeutics, Inc.
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lower Eyelid Steatoblepharon Severity (LESS) Score--Clinician-Reported |
27; 6 | 0.020 sig |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02230761). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.