Phase 2 Study of XAF5 (XOPH5) Ointment for Reduction of Excess Eyelid Fat (Steatoblepharon)

January 9, 2016 updated by: Topokine Therapeutics, Inc.

A Phase 2, Randomized, Double-masked, Placebo-controlled Study of XOPH5 Ointment for Reduction of Lower Lid Steatoblepharon

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Topokine Therapeutics Clinical Study Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: XOPH5 Ointment
XOPH5 Ointment is the investigational drug to be studied.
Drug: XOPH5 Ointment
Placebo Comparator: Placebo Ointment
Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower Eyelid Steatoblepharon Severity (LESS) Score--Clinician-Reported
Time Frame: 11 weeks
Photonumeric scale, range 0-4, 0 is absence of steatoblepharon, 4 is very severe steatoblepharon.
11 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction Scale 1 (PSS1)
Time Frame: 0-11 weeks
Change from Baseline to Week 11 in PSS1 score. PSS1 scale items use an ordinal scale with range 0-10, where 0 is the least favorable and 10 is the most favorable. The composite score is the sum of 6 items and has a possible response range of 0 to 60.
0-11 weeks
Patient Satisfaction Scale 2 (PSS2)
Time Frame: 11 weeks
Composite score on PSS2 scale. PSS2 is an ordinal scale with range 1-7, where 1 is least favorable and 7 is most favorable. The composite score is the sum of 3 items and has a possible response range of 3 to 21.
11 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Topokine Therapeutics, Inc.

Investigators

  • Study Chair: Michael S. Singer, MD, PhD, Topokine Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

August 28, 2014

First Submitted That Met QC Criteria

September 2, 2014

First Posted (Estimate)

September 3, 2014

Study Record Updates

Last Update Posted (Estimate)

February 8, 2016

Last Update Submitted That Met QC Criteria

January 9, 2016

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • XOPH5-OINT-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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