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A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis

NCT06135415 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2026-03-25

No results posted yet for this study

Summary

The purpose of the study is to evaluate the efficacy and safety of tirbanibulin 10 milligrams per gram (mg/g) ointment when applied to a treatment field (TF) larger than 25 centimeter square (cm\^2) and up to 100 cm\^2 in adult participants with actinic keratosis (AK).

Conditions

  • Keratosis, Actinic

Interventions

DRUG

Tirbanibulin

Participants will apply tirbanibulin ointment topically on the face or balding scalp with AK.

OTHER

Vehicle ointment

Participants will apply vehicle ointment topically on the face or balding scalp with AK.

Sponsors & Collaborators

  • Almirall, S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-21
Primary Completion
2025-04-30
Completion
2025-11-25
FDA Drug
Yes

Countries

  • Germany
  • Italy
  • Netherlands
  • Poland
  • Spain

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 NCT06135415 on ClinicalTrials.gov