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

Almirall, S.A.280 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

280

Conditions

Keratosis, Actinic

Interventions

TirbanibulinDRUG

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

Vehicle ointmentOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants having a TF on the face or balding scalp (excluding lips, eyelids, and inside nostrils and ears) that contains \>= 4 to less than or equal to (\<=) 12 clinically typical, visible, and discrete (non-confluent) AK lesions and measures more than 25 cm2 (example, one cheek) and up to approximately 100 cm2 (example, mid face). * Participants willing to avoid excessive sunlight or UV light exposure, including the use of tanning beds, to the face or scalp during the study. * Women of childbearing potential (WOCBP), that is, fertile, defined as a female in the life period from menarche and until becoming post-menopausal (no menses for 12 months without an alternative medical cause) or permanently sterile (with hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least 3 months prior to screening) must have a negative urine pregnancy test using a highly sensitive method at screening and on Day 1 prior to treatment administration, be using highly effective methods of birth control for at least 30 days or 1 menstrual cycle, whichever is longer, and until at least 30 days or 1 menstrual period, whichever is longer, after the last dose of investigational product, agree to have pregnancy tests while in the study and at the end of the study, and agree not to be egg (oocyte) donors while on study and until at least 30 days or 1 menstrual period, whichever is longer, after the last dose of investigational product. * Sexually active males with female partners who are WOCBP must agree to use two forms of contraception, one of which must be barrier contraception, from screening through 90 days after their last dose of study treatment. All non-sterile male participants must agree not to donate sperm or attempt conception from screening through 90 days following their last dose of study treatment. * Participants should have 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: * Participants with clinically atypical and/or rapidly changing AK lesions in the TF; hyperkeratotic or hypertrophic lesions, recalcitrant disease (defined as failure to respond to cryosurgery on 2 previous occasions) and/or cutaneous horn; history of invasive SCC, Bowen's disease, BCC, or other malignant tumors in the TF; any other dermatological disease that causes difficulty with examination. * Location of the TF is on any location other than the face or balding scalp, within 5 centimeter (cm) of an incompletely healed wound, within 5 cm of a suspected BCC or other neoplasms, periorbital, lips, or nostrils. * Participants having a previous treatment with tirbanibulin 10 mg/g ointment. * Females who are pregnant or nursing or seeking to become pregnant. * Participants having intention to use any concomitant medication that is not permitted by this protocol or failure to undergo the required washout period for a particular prohibited medication or therapy. * Participants with anticipated need for inpatient hospitalization or inpatient surgery from Day 1 to Day 113. * Participants with history of sensitivity and/or allergy to any of the ingredients in the study medication. * Participants with significant abnormalities on the medical history, physical examination (PE) findings, vital signs, clinical chemistry, or hematology results that in the judgment of the investigator may interfere with the interpretation of the results. * Participants with skin disease (example; atopic dermatitis, psoriasis, eczema) or condition (example; scarring, open wounds) that, in the opinion of the investigator, might interfere with the study conduct or evaluations, or which exposes the participant to unacceptable risk by study participation. * Participants with significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the investigator, would expose the participant to unacceptable risk by study participation. * Participants who have participated in an investigational drug trial during which an investigational study medication was administered within 30 days or 5 half-lives of the investigational product, whichever is longer, before dosing in the current study. * Participant who is employee or a relative to an employee at the research site or the Sponsor.

Locations (35)

Site 17

Augsburg, Germany

Outcomes

Primary Outcomes

Percent Change From Baseline in Lesion Count at Day 57

Percentage change from baseline in the AK lesion count will be assessed.

Time frame: Baseline, Day 57

Secondary Outcomes

Proportion of Participants With Partial Clearance (PC) at Day 57

PC is defined as proportion of participants achieving more than or equal to (\>=) 75 percent (%) clearance of AK lesions in the TF on the face or scalp at Day 57.

Time frame: At Day 57

Proportion of Participants With Complete Clearance (CC) at Day 57

CC is defined as proportion of participants achieving 100 percent clearance of AK lesions in the TF on the face or scalp at Day 57.

Time frame: At Day 57

Proportion of Participants With Partial Clearance (PC) by Day 113

Time frame: Baseline up to Day 113

Proportion of Participants With Complete Clearance (CC) by Day 113

Time frame: Baseline up to Day 113

Total Number of Lesions per Participant in the TF at Specific Timepoints

Time frame: Baseline, Day 8, 15, 29, 57, 64, 71, 85, and 113

Percent Change From Baseline in lesion count in the TF at Specific Timepoints

Time frame: Baseline, Day 8, 15, 29, 57, 64, 71, 85, and 113

Number of New Lesions per Participant in the TF at Specific Timepoints

Number of new lesions that are not present at baseline, occurring per participant in the TF at specific timepoints will be assessed.

Data from ClinicalTrials.gov

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Site 1

Bad Bentheim, Germany

Site 3

Bochum, Germany

Site 18

Dresden, Germany

Site 2

Hamburg, Germany

Site 5

Hamburg, Germany

Site 4

Mahlow, Germany

Site 6

Wuppertal, Germany

Site 25

Bologna, Italy

...and 25 more locations

Time frame: At Day 8, 15, 29, 57, 64, 71, 85, and 113

Number of Baseline Lesions per Participant Present in the TF at Specific Timepoints

Number of lesions per participant in the TF at specific timepoints will be assessed.

Time frame: Baseline, Day 8, 15, 29, 57, 64, 71, 85, and 113

Change From Baseline in Skindex-16 Questionnaire Overall Score and Domain Scores (Symptoms, Emotions, and Functioning) at Day 57

Skindex-16 is used for participants to rate skin conditions that have occurred within the previous week. It is a short 16-item patient-completed assessment that are classified into three domains: symptoms \[four items, 1-4\], emotions, \[seven items, 5-11\] and functioning \[five items, 12-16\]. All items are scored on a seven-point numerical analogue scales (0=never bothered to 6=always bothered). Each item is then transformed to a linear scale from 0 (never bothered) to 100 (always bothered), where higher the score = more severe in impairment. The total score is the average of all 16 items scores ranging from 0 \[best Health Related Quality of Life (HRQoL)\] to 96 (worst HRQoL), where higher score indicates worst quality of life.

Time frame: Baseline, Day 57

Change from Baseline in Skindex-16 Questionnaire Overall Score and Domain Scores (Symptoms, Emotions, and Functioning) at Day 113 in Participants who Receive 2 Treatment Courses

Time frame: Baseline, Day 113

Cosmetic Outcome as Assessed by the Participant at Day 57

Cosmetic Outcome is rated on a 4-point scale as excellent (no or mild redness or change in pigmentation), good (moderate redness or change in pigmentation), fair (slight-to-moderate scarring, atrophy, or induration), and poor (extensive scarring, atrophy, or induration).

Time frame: At Day 57

Cosmetic Outcome as Assessed by the Investigator at Day 57

Time frame: At Day 57

Cosmetic Outcome in Participants who Receive 2 Treatment Courses, as Assessed by Participants at Day 113

Time frame: At Day 113

Cosmetic Outcome in Participants who Receive 2 Treatment Courses, as Assessed by Investigator at Day 113

Time frame: At Day 113

Treatment Satisfaction Questionnaire for Medications (TSQM) Transformed Total Scores at Day 57

The TSQM-14 is a participant-rated scale used to assess subjective satisfaction with medication. The TSQM-14 provided scores on 4 domains: effectiveness (questions 1 to 3) side effects (4 to 8), convenience (9 to 11), and global satisfaction (12 to 14). With the exception of item 4 (presence of side effects; yes or no), all items have five or seven responses, scored from one (least satisfied) to five or seven (most satisfied). Scores for each domain were transformed into a final score ranging from 0 to 100, with higher numbers indicating a higher level of satisfaction.

Time frame: At Day 57

TSQM Transformed Scores in Participants who Receive 2 Treatment Courses at Day 113

Time frame: At Day 113

Local Tolerability Score at Specific Timepoints for Each Individual Sign

Local tolerability score is evaluated by the investigator in terms of presence and absence of erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration signs and its severity in the areas of body where medication is applied. These symptoms are assessed by using a 4-point scale of 0-3, where 0 (absent) and 3 (severe). The higher score indicates severe symptoms.