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A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis

A Phase 3, Multicenter, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% Applied to a Field of Approximately 100 cm2 on the Face or Balding Scalp in Adult Patients With Actinic Keratosis

NCT05279131•Almirall, S.A.

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the safety, tolerability and treatment effect of tirbanibulin ointment 1% when applied to a field of approximately 100 cm\^2 on the face or balding scalp.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Having a treatment field (TF) on the face or balding scalp (excluding lips, eyelids, and inside nostrils and ears) that measures approximately 100 cm\^2 (eg, mid face) and contains 4 to 12 clinically typical, visible, and discrete actinic keratosis (AK) lesions within the TF
•Willing to avoid excessive sunlight or ultraviolet (UV) light exposure, including the use of tanning beds, to the face or scalp during the study
•Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and provided written informed consent in accordance with institutional and regulatory guidelines
•4. History of invasive squamous cell carcinoma (SCC), Bowen's disease, basal cell carcinoma (BCC), or other malignant tumors in the TF
•5. Any other dermatological disease that causes difficulty with examination
•Previous treatment with tirbanibulin ointment 1%.
•Anticipated need for inpatient hospitalization or inpatient surgery from Day 1 to Day 57
•Treatment with 5-fluorouracil, imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for AK within the TF or within 2 cm of the TF, within 8 weeks prior to the Screening visit
•Use of systemic retinoids (eg, isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit

Exclusion Criteria

•Presence in the TF of
•1. Clinically atypical and/or rapidly changing AK lesions in the TF
•2. Hyperkeratotic or hypertrophic lesions, recalcitrant disease (had cryosurgery on 2 previous occasions) and/or cutaneous horn

Locations (7)

Almirall Investigation Site 7

Hot Springs, Arkansas, United States

Almirall Investigation Site 6

Encinitas, California, United States

Almirall Investigation Site 3

Sweetwater, Florida, United States

Almirall Investigation Site 5

Rolling Meadows, Illinois, United States

Almirall Investigation Site 4

Austin, Texas, United States

Almirall Investigational Site 1

College Station, Texas, United States

Almirall Investigation Site 2

San Antonio, Texas, United States

Key Dates

Start Date

June 28, 2022

Primary Completion Date

December 28, 2022

Completion Date

December 28, 2022

Last Updated

January 23, 2024

Enrollment

105

ACTUAL participants

Conditions

Keratosis, Actinic

Interventions

Tirbanibulin ointment 1%

DRUG

The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy

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Keratosis, Actinic

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Keratosis, Actinic

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Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK)

NCT01458587

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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