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

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ClinicalTrials.gov Identifier: NCT02607683
Recruitment Status : Completed
First Posted : November 18, 2015
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Steatoblepharon Drug: XAF5 (concentration A: 0.1%) Drug: XAF5 (concentration B: 0.035%) Drug: Matching placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b/3, Multicenter, Dose-ranging, Randomized, Double-masked, Placebo-controlled Study of XAF5 Ointment for Reduction of Lower Lid Steatoblepharon
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : September 19, 2016
Actual Study Completion Date : October 31, 2016

Arm Intervention/treatment
Experimental: XAF5 (concentration A: 0.1%)
Participants will apply XAF5 Ointment (concentration A: 0.1%) to the lower eyelids once daily.
Drug: XAF5 (concentration A: 0.1%)
Experimental: XAF5 (concentration B: 0.035%)
Participants will apply XAF5 Ointment (concentration B: 0.035%) to the lower eyelids once daily.
Drug: XAF5 (concentration B: 0.035%)
Placebo Comparator: Placebo
Participants will apply Placebo Ointment to the lower eyelids once daily.
Drug: Matching placebo



Primary Outcome Measures :
  1. LESS score (Clinician-Reported) [ Time Frame: 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02607683


Locations
United States, California
David Wirta, MD, Inc.
Newport Beach, California, United States
OC Clinical Trials
Santa Ana, California, United States
United States, Connecticut
Danbury Eye Physicians
Danbury, Connecticut, United States
United States, Massachusetts
Opthalmic Consultants of Boston
Boston, Massachusetts, United States
United States, New York
South Shore Eye Care, Inc.
Wantagh, New York, United States
United States, Ohio
Cincinatti Eye Institute
Cincinnati, Ohio, United States
Sponsors and Collaborators
Topokine Therapeutics, Inc.
Investigators
Study Director: Julie Roth, Ph.D. Allergan

Responsible Party: Topokine Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02607683     History of Changes
Other Study ID Numbers: XOPH5-OINT-3
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017