Phase 2b/3 Study of XAF5 Ointment for Steatoblepharon (Undereye Bags)
NCT ID: NCT02607683
Last Updated: 2017-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
300 participants
INTERVENTIONAL
2016-01-01
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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XAF5 (concentration A: 0.1%)
Participants will apply XAF5 Ointment (concentration A: 0.1%) to the lower eyelids once daily.
XAF5 (concentration A: 0.1%)
XAF5 (concentration B: 0.035%)
Participants will apply XAF5 Ointment (concentration B: 0.035%) to the lower eyelids once daily.
XAF5 (concentration B: 0.035%)
Placebo
Participants will apply Placebo Ointment to the lower eyelids once daily.
Matching placebo
Interventions
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XAF5 (concentration A: 0.1%)
XAF5 (concentration B: 0.035%)
Matching placebo
Eligibility Criteria
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Inclusion Criteria
* Must understand and provide informed consent
* Healthy facial skin
Exclusion Criteria
* 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
40 Years
70 Years
ALL
No
Sponsors
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Topokine Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Julie Roth, Ph.D.
Role: STUDY_DIRECTOR
Allergan
Locations
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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
Countries
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Other Identifiers
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XOPH5-OINT-3
Identifier Type: -
Identifier Source: org_study_id