Phase 2b/3 Study of XAF5 Ointment for Steatoblepharon (Undereye Bags)

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Steatoblepharon

In brief

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).

Key facts

Study ID

NCT02607683

Run by

Topokine Therapeutics, Inc.

People needed

300

Starts

2016-01-01

Expected to finish

2016-10-31

Last updated by the study team

2017-11-08

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Moderate to severe, bilateral lower eyelid steatoblepharon
• Must understand and provide informed consent
• Healthy facial skin

You may not qualify if…

• 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

Where it is running

• David Wirta, MD, Inc. — Newport Beach, California, United States
• OC Clinical Trials — Santa Ana, California, United States
• Danbury Eye Physicians — Danbury, Connecticut, United States
• Opthalmic Consultants of Boston — Boston, Massachusetts, United States
• South Shore Eye Care, Inc. — Wantagh, New York, United States
• Cincinatti Eye Institute — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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