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Microtubule Inhibitor

Tirbanibulin ointment 1% for Actinic Keratosis

Phase 3

Waitlist Available

Research Sponsored by Almirall, S.A.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, day 57

Awards & highlights

Study Summary

This trial is testing a new ointment to see if it is safe and effective for treating a large area on the face or scalp.

Eligible Conditions

Actinic Keratosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, day 57

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, day 57

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 57 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Local Tolerability Signs Total Composite Score by Visit at Day 15

Local Tolerability Signs Total Composite Score by Visit at Day 29

Local Tolerability Signs Total Composite Score by Visit at Day 5

+21 more

Side effects data

From 2022 Phase 3 trial • 105 Patients • NCT05279131

10%

Application site pruritus

Application site pain

Dizziness

Paraesthesia

Actinic keratosis

Failure to thrive

Tachycardia

Vitamin D deficiency

Pain in extremity

Hypercalcaemia

Oedema peripheral

Asthenia

Squamous cell carcinoma

Encephalopathy

Application site bruise

Bronchitis

Tooth abscess

Application site hypoaesthesia

Atrial fibrillation

Arthropod sting

Metastatic neoplasm

Application site dryness

Acute kidney injury

COVID-19

Laryngitis viral

Dermatitis

Tenderness

Influenza

Skin abrasion

Osteoarthritis

100%

80%

60%

40%

20%

Study treatment Arm

Tirbanibulin (Klisyri®)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tirbanibulin (Klisyri®)Experimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tirbanibulin ointment 1%

2022

Completed Phase 3

~110

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Almirall, S.A.Lead Sponsor

58 Previous Clinical Trials

17,598 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Tirbanibulin ointment 1% received government approval for use?

"There is some evidence to support the efficacy of Tirbanibulin ointment 1% based on Phase 3 data, meaning that the drug has undergone multiple rounds of safety testing."

Answered by AI

Are we actively looking for participants in this experiment?

"Data from clinicaltrials.gov tells us that this particular trial is no longer recruiting patients, having first been posted on June 8th, 2022 and last edited November 11th of the same year. Although this specific study has wrapped up recruitment, there are 25 other trials looking for volunteers as we speak."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05279131.