Overview

This trial is active, not recruiting.

Condition steatoblepharon
Treatments xaf5 (concentration a: 0.1%), xaf5 (concentration b: 0.035%), matching placebo
Phase phase 2/phase 3
Sponsor Topokine Therapeutics, Inc.
Start date January 2016
End date November 2017
Trial size 300 participants
Trial identifier NCT02607683, XOPH5-OINT-3

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Participants will apply XAF5 Ointment (concentration A: 0.1%) to the lower eyelids once daily.
xaf5 (concentration a: 0.1%)
(Experimental)
Participants will apply XAF5 Ointment (concentration B: 0.035%) to the lower eyelids once daily.
xaf5 (concentration b: 0.035%)
(Placebo Comparator)
Participants will apply Placebo Ointment to the lower eyelids once daily.
matching placebo

Primary Outcomes

Measure
LESS score (Clinician-Reported)
time frame: 16 weeks

Eligibility Criteria

Male or female participants from 40 years up to 70 years old.

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

Additional Information

Official title A Phase 2b/3, Multicenter, Dose-ranging, Randomized, Double-masked, Placebo-controlled Study of XAF5 Ointment for Reduction of Lower Lid Steatoblepharon
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Topokine Therapeutics, Inc..