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

NCT02607683 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2017-11-08

No results posted yet for this study

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).

Conditions

  • Steatoblepharon

Interventions

DRUG

XAF5 (concentration A: 0.1%)

DRUG

XAF5 (concentration B: 0.035%)

DRUG

Matching placebo

Sponsors & Collaborators

  • Topokine Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Julie Roth, Ph.D. · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2016-09-19
Completion
2016-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02607683 on ClinicalTrials.gov