New ointment could treat larger patches of Sun-Damaged skin

NCT ID NCT06135415

Disease control Sponsor: Almirall, S.A. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times

Summary

This study tested an ointment called tirbanibulin (Klisyri®) on adults with actinic keratosis, a common precancerous skin condition caused by sun exposure. The trial included 280 participants and applied the ointment to larger skin areas (up to 100 cm²) on the face or balding scalp. The goal was to see if it safely reduces the number of lesions compared to a placebo ointment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: tirbanibulin ointment (Klisyri®)
What this could lead to: If successful, this could provide a treatment option for larger areas of actinic keratosis, reducing the number of precancerous skin lesions.
What could go wrong: This is a completed Phase 3 trial, but results are not yet published. The treatment may cause skin reactions and may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

280 people

The number who actually took part.

Started

Dec 2023

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

actinic keratosis keratosis neoplasm precancerous condition

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Keratosis, actinic

Contacts and locations

Locations

Site 1

Bad Bentheim, Germany
Site 10

Warsaw, Poland
Site 11

Warsaw, Poland
Site 12

Barcelona, Spain
Site 13

Madrid, Spain
Site 14

Barcelona, Spain
Site 15

Valencia, Spain
Site 16

Zaragoza, Spain
Site 17

Augsburg, Germany
Site 18

Dresden, Germany
Site 19

Brescia, Italy
Site 2

Hamburg, Germany
Site 20

Roma, Italy
Site 21

Roma, Italy
Site 22

Pisa, Italy
Site 23

Florence, Italy
Site 24

Bari, Italy
Site 25

Bologna, Italy
Site 26

Cagliari, Italy
Site 27

Reggio Emilia, Italy
Site 28

Maastricht, Netherlands
Site 29

Heemstede, Netherlands
Site 3

Bochum, Germany
Site 30

Ossy, Poland
Site 31

Krakow, Poland
Site 32

Salamanca, Spain
Site 33

Granada, Spain
Site 34

Barcelona, Spain
Site 35

Valencia, Spain
Site 4

Mahlow, Germany
Site 5

Hamburg, Germany
Site 6

Wuppertal, Germany
Site 7

Roma, Italy
Site 8

Wroclaw, Poland
Site 9

Warsaw, Poland

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