Phase 2b/3 Study of XAF5 Ointment for Steatoblepharon (Undereye Bags)
Phase 2
Completed
- Conditions
- Steatoblepharon
- Interventions
- Drug: Matching placebo
- Registration Number
- NCT02607683
- Lead Sponsor
- Topokine Therapeutics, Inc.
- Brief Summary
This randomized, placebo-controlled, double-masked, Phase 2b/Phase 3 study will assess the efficacy of two different concentrations of XAF5 Ointment for reduction of lower lid steatoblepharon (undereye bags).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
- Moderate to severe, bilateral lower eyelid steatoblepharon
- Must understand and provide informed consent
- Healthy facial skin
Exclusion Criteria
- Pregnant or lactating women
- Clinically significant eye disease
- Best corrected visual acuity worse than 20/40 in either eye
- History of eye surgery in past 6 months
- History of lower eyelid surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Matching placebo Participants will apply Placebo Ointment to the lower eyelids once daily.
- Primary Outcome Measures
Name Time Method LESS score (Clinician-Reported) 16 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
David Wirta, MD, Inc.
🇺🇸Newport Beach, California, United States
Danbury Eye Physicians
🇺🇸Danbury, Connecticut, United States
South Shore Eye Care, Inc.
🇺🇸Wantagh, New York, United States
OC Clinical Trials
🇺🇸Santa Ana, California, United States
Opthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
Cincinatti Eye Institute
🇺🇸Cincinnati, Ohio, United States