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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-28

Study Completion Date

2022-12-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Keratosis, Actinic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tirbanibulin (Klisyri®)

Participants will apply tirbanibulin ointment 1% once daily for 5 days beginning Day 1. Participants will be evaluated for safety, tolerability, and the presence of Actinic Keratosis (AK) lesions in the treatment field (TF) until completion of the response assessment period at Day 57.

Group Type EXPERIMENTAL

Tirbanibulin ointment 1%

Intervention Type DRUG

Applied topically for 5 days over a field of approximately 100 cm\^2 on the face or balding scalp with AK.

Interventions

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Tirbanibulin ointment 1%

Applied topically for 5 days over a field of approximately 100 cm\^2 on the face or balding scalp with AK.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No