Outcomes Associated With Tirbanibulin for Large Field Application on the Face in the U.S (CLEAR)

Part of paid clinical trials in Manhattan Beach, California.

Sponsor
Avant Health LLC
Study ID
NCT07657988
Status
Recruiting

Conditions

  • Actinic Keratosis (AK)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tirbanibulin — DRUG
    Participants receiving tirbanibulin ointment 1% (3.5 mg tirbanibulin in 350 mg) as 1 single-dose packet per application, for 5 consecutive days

Study Details

The goal of this observational study is to learn about the effectiveness of tirbanibulin among adult subjects with actinic keratosis (AK) lesions in the face. The main question it aim to answer is: How does tirbanibulin improve subject's overall appearance of the skin, improve how patient's skin looks, and improve patient's skin texture, in a 57-day observation period. Participants already taking tirbanibulin as part of their regular medical care for AK will answer online survey questions at the beginning of the study and at Day 57.

Key Dates

Start date
Apr 2, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Tirbanibulin
    Participants will receive tirbanibulin ointment 3.5 mg in 350 mg (as 1 single-dose packet per application, for 5 consecutive days). The participants will be observed for 57 days to gather participant reported outcomes (PROs) and clinical profile.

Primary Outcome Measure

Subject and clinician rating of current 'overall appearance of the skin' in the original AK treated area [ Time Frame: At end of study observation period, at day 57 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Ablon Skin Institute and Research CenterManhattan BeachCalifornia90266
Glynis Ablon, MD
310-727-3376
Glynis Ablon, MD (PRINCIPAL_INVESTIGATOR)
Dermatology & Laser Center of CharlestonCharlestonSouth Carolina29414
Todd Schlesinger, MD
843.377.2201
Todd Schlesinger, MD (PRINCIPAL_INVESTIGATOR)

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