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Completed

NCT Number: NCT02230761

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

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Key information

Conditions

Lower Eyelid Steatoblepharon (Excess Eyelid Fat) Blepharoptosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cutis Laxa Eye Diseases Eyelid Diseases Genetic Diseases, Inborn Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Topokine Therapeutics Clinical Study Centers

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XOPH5 Ointment

Drug

Placebo

Drug

Primary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Topokine Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 3, 2014
Registry last updated
Feb 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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