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Completed

NCT Number: NCT02607683

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

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).

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Key information

Conditions

Steatoblepharon

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

David Wirta, MD, Inc., Newport Beach, California, United States

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

XAF5 (concentration A: 0.1%)

Drug

XAF5 (concentration B: 0.035%)

Drug

Matching Placebo

Drug

Primary outcomes

  1. LESS score (Clinician-Reported)

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Topokine Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 2b/3, Multicenter, Dose-ranging, Randomized, Double-masked, Placebo-controlled Study of XAF5 Ointment for Reduction of Lower Lid Steatoblepharon

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 18, 2015
Registry last updated
Nov 8, 2017

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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