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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02607683

Enrollment

300

Registered

2015-11-18

Start date

2016-01-01

Completion date

2016-10-31

Last updated

2017-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Steatoblepharon

Brief 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).

Interventions

DRUGXAF5 (concentration A: 0.1%)

DRUGXAF5 (concentration B: 0.035%)

DRUGMatching placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
LESS score (Clinician-Reported)	16 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026