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Microtubule Inhibitor
A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With 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
No Placebo-Only Group
Pivotal Trial
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSide effects data
From 2022 Phase 3 trial • 105 Patients • NCT0527913110%
Application site pruritus
9%
Application site pain
2%
Dizziness
2%
Paraesthesia
1%
Tachycardia
1%
Asthenia
1%
Oedema peripheral
1%
Influenza
1%
Laryngitis viral
1%
COVID-19
1%
Skin abrasion
1%
Failure to thrive
1%
Hypercalcaemia
1%
Metastatic neoplasm
1%
Tooth abscess
1%
Vitamin D deficiency
1%
Osteoarthritis
1%
Squamous cell carcinoma
1%
Encephalopathy
1%
Acute kidney injury
1%
Atrial fibrillation
1%
Application site bruise
1%
Application site dryness
1%
Application site hypoaesthesia
1%
Tenderness
1%
Bronchitis
1%
Pain in extremity
1%
Dermatitis
1%
Arthropod sting
1%
Actinic keratosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tirbanibulin (Klisyri®)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
Find a Location
Who is running the clinical trial?
Almirall, S.A.Lead Sponsor
61 Previous Clinical Trials
18,141 Total Patients Enrolled