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

Topokine Therapeutics

Status and phase: Completed; Phase 3; Phase 2

Conditions: Steatoblepharon

Treatments: Drug: XAF5 (concentration B: 0.035%); Drug: XAF5 (concentration A: 0.1%); Drug: Matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02607683

XOPH5-OINT-3

Details and patient eligibility

About

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).

Enrollment: 300 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 3 patient groups, including a placebo group

XAF5 (concentration A: 0.1%)

Experimental group

Description:

Participants will apply XAF5 Ointment (concentration A: 0.1%) to the lower eyelids once daily.

Treatment:

Drug: XAF5 (concentration A: 0.1%)

XAF5 (concentration B: 0.035%)

Experimental group

Description:

Participants will apply XAF5 Ointment (concentration B: 0.035%) to the lower eyelids once daily.

Treatment:

Drug: XAF5 (concentration B: 0.035%)

Placebo

Placebo Comparator group

Description:

Participants will apply Placebo Ointment to the lower eyelids once daily.

Treatment:

Drug: Matching placebo