Optic

ID

Name

M-14867-32

Description

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.

Trial arms

Trial start

2022-06-28

Estimated PCD

2022-12-28

Trial end

2022-12-28

Status

Completed

Phase

Early phase I

Treatment

Tirbanibulin ointment 1%

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

Arms:

Tirbanibulin (Klisyri®)

Size

105

Primary endpoint

Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 5

Baseline, Day 5

Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 8

Baseline, Day 8

Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 15

Baseline, Day 15

Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 29

Baseline, Day 29

Number of Participants Categorized by Local Tolerability Score by Visit for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration) at Day 57

Baseline, Day 57

Number of Participants With Maximum Local Tolerability Score Post-baseline for Each Individual Signs (Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration)

Baseline, Maximum post-baseline (up to Day 57)

Time to Maximum Local Tolerability Score for Erythema, Flaking/Scaling, Crusting, Swelling, Vesiculation/Pustulation, and Erosion/Ulceration

Baseline up to Day 57

Local Tolerability Signs Total Composite Score by Visit at Day 5

Baseline, Day 5

Local Tolerability Signs Total Composite Score by Visit at Day 8

Baseline, Day 8

Local Tolerability Signs Total Composite Score by Visit at Day 15

Baseline, Day 15

Local Tolerability Signs Total Composite Score by Visit at Day 29

Baseline, Day 29

Local Tolerability Signs Total Composite Score by Visit at Day 57

Baseline, Day 57

Maximum Local Tolerability Signs Total Composite Score Post Baseline

Baseline, Maximum post-baseline (up to Day 57)

Time to Maximum Local Tolerability Total Composite Score

Baseline up to Day 57

Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 5

Baseline, Day 5

Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 8

Baseline, Day 8

Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 15

Baseline, Day 15

Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 29

Baseline, Day 29

Number of Participants With Pigmentation and Scarring in the Treatment Area by Visit at Day 57

Baseline, Day 57

Number of Participants With Any Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs)

Baseline up to Day 57

Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters

Baseline up to Day 57

Number of Participants With Clinically Significant Abnormalities in Vital Signs

Baseline up to Day 57

Number of Participants With Clinically Significant Abnormalities in Physical Examination

Baseline up to Day 57

Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)

Baseline up to Day 57

Eligibility criteria

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 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 3. Confluent AK lesions (ie, non-discrete lesions defined as per inclusion criteria) 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 105, 'type': 'ACTUAL'}}

Updated at

2024-01-23

Organization

Product

Indication

Indication

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