Study on the Effectiveness and Safety of Tirbanibulin Ointment for Adults with Actinic Keratosis on the Face or Scalp

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What is this study about?

This clinical trial is focused on studying a skin condition called Actinic Keratosis, which often appears on the face or scalp. This condition is characterized by rough, scaly patches on the skin caused by long-term exposure to the sun. The study will evaluate the effectiveness and safety of a treatment called Tirbanibulin 10 mg/g ointment, also known by its code name KX2-391. This ointment is applied directly to the skin and is being tested to see how well it works in clearing the affected areas.

The purpose of the study is to assess how effective Tirbanibulin is in treating Actinic Keratosis compared to a placebo, which looks like the treatment but does not contain the active ingredient. Participants in the study will apply the ointment to a specific area of their skin that is larger than 25 cm² and up to 100 cm². The study will last for several weeks, with the main evaluation taking place at Day 57, which is about eight weeks after starting the treatment. Some participants may receive a second course of treatment, and their progress will be checked again by Day 113.

Throughout the study, the number of skin lesions will be counted and compared to the initial count to determine the treatment’s effectiveness. The study aims to see if there is a significant reduction in the number of lesions and if the skin clears up completely in some cases. This research is important for finding better ways to manage and treat Actinic Keratosis, providing valuable information on the potential benefits of Tirbanibulin ointment for patients with this condition.

1 Joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, such as age and the presence of actinic keratosis (AK) on the face or scalp.

Participants must agree to avoid excessive sunlight or UV light exposure during the study.

2 Initial assessment

An initial assessment is conducted to document the number and size of AK lesions.

A treatment field (TF) is identified, which must measure more than 25 cm² and up to 100 cm².

3 Treatment administration

Participants are randomly assigned to receive either tirbanibulin 10 mg/g ointment or a placebo ointment, referred to as the vehicle.

The ointment is applied cutaneously to the TF once daily for five consecutive days.

4 Follow-up assessments

Follow-up assessments occur at various intervals to evaluate the efficacy of the treatment.

The primary assessment is conducted on Day 57 to measure the percent change in lesion count.

5 Secondary assessments

Secondary assessments include evaluating the proportion of patients with partial clearance (PC) and complete clearance (CC) of lesions by Day 57 and Day 113.

PC is defined as 75% clearance, and CC is defined as 100% clearance of lesions.

6 Completion of the study

The study concludes with a final assessment to determine the overall effectiveness and safety of the treatment.

Participants are monitored for any side effects or adverse reactions throughout the study duration.

Who Can Join the Study?

Patients must have Actinic Keratosis (AK), which are rough, scaly patches on the skin, and be 18 years or older.
Patients should have a treatment field (TF) on the face or balding scalp, excluding lips, eyelids, and inside nostrils and ears, that contains between 4 to 12 visible and separate AK lesions. The area should be more than 25 square centimeters (about the size of one cheek) and up to approximately 100 square centimeters (about the size of the mid-face).
Patients must be willing to avoid too much sunlight or UV light exposure, including tanning beds, on the face or scalp during the study.
Women who can have children must have a negative pregnancy test before starting the study and use highly effective birth control methods during the study and for a period after the study ends. They must also agree to have pregnancy tests during and at the end of the study and not donate eggs during the study and for a period after it ends.
Sexually active males with female partners who can have children must agree to use two forms of birth control, one being a barrier method like a condom, during the study and for 90 days after their last dose of study treatment. They must also agree not to donate sperm or try to conceive during this time.
Patients must be able to understand the purpose and risks of the trial, be willing and able to follow the study rules, and provide written consent to participate.

Who Cannot Join the Study?

Patients who do not have Actinic Keratosis on the face or scalp cannot participate. Actinic Keratosis is a rough, scaly patch on the skin caused by sun exposure.
Patients who are not adults are excluded. This means only individuals who are 18 years or older can participate.
Patients who are unable to follow the study procedures or attend all required visits are not eligible.
Patients who have used certain treatments for Actinic Keratosis recently may be excluded. This includes treatments like creams or procedures that could affect the study results.
Patients with other skin conditions that might interfere with the study results are not eligible.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may be excluded.
Patients with a known allergy to any ingredient in the study ointment cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Evimed Sp. z o.o.	Warsaw	Poland
University Hospital Maastricht	Maastricht	The Netherlands
Hospital Universitario De Salamanca	Salamanca	Spain
Technische Universitaet Dresden	Dresden	Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Navarra	Pamplona	Spain
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy
Royalderm Agnieszka Nawrocka	Warsaw	Poland

Other Sites

Site Name	City	Country
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.	Wroclaw	Poland
Klinika Ambroziak Sp. z o.o.	Warsaw	Poland
Hospital Clinic De Barcelona	Barcelona	Spain
Universita’ Di Pisa	Pisa	Italy
Hospital General Universitario De Valencia	Valencia	Spain
Universita Degli Studi Di Brescia	Brescia	Italy
CentroDerm GmbH	Wuppertal	Germany
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR	Blankenfelde-Mahlow	Germany
Dr. Niesmann And Dr. Othlinghaus GbR	Bochum	Germany
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.	Cracow	Poland
Azienda Ospedaliera Universitaria Di Cagliari	Monserrato	Italy
Labderm Essence Sp. z o.o.	Ozarowice	Poland
University Hospital Consorziale Policlinico	Bari	Italy
Dmgmbdfzch Swi z oqux	Wroclaw	Poland
Dyraq Shljaix Glzj	Hamburg	Germany
Arruyys Uyj Ibpmj Dk Rkjoxo Erubqt	Reggio Emilia	Italy
Agjukzk Uqmlo Sdlijchup Lvpynz Dy Brluccf	Bologna	Italy
Hrqlfteh Db Ll Ssbyc Ckoj I Sned Pzd	Barcelona	Spain
Unftqshjdf Mlgouvs Chtoop Hfxcvuvmqkbddwtwy	Hamburg	Germany
Uwdvbcsxnc Dafjv Snwvo Du Rxab La Scvcwrhx	Rome	Italy
Uzbcqzrmhtqcxzzxfuihx Aexanpkf	Augsburg	Germany
Ttwhoialibt udr Srtvxziyppg Byfhmajj Gbrh	Bad Bentheim	Germany
Hxwtfgiy Vzpr dishzekr	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	01.12.2023
Italy	Not recruiting	01.12.2023
Poland	Not recruiting	01.12.2023
Spain	Not recruiting	01.12.2023
The Netherlands	Not recruiting	01.12.2023

Trial locations

Investigated drugs:

Tirbanibulin

Tirbanibulin is an ointment used in this clinical trial to treat actinic keratosis, which is a skin condition caused by sun damage. The ointment is applied to the affected area on the face or scalp to help clear the lesions. The study aims to evaluate how effective and safe this treatment is when used on a larger area of skin.

Investigated diseases:

Actinic keratosis

Actinic Keratosis – Actinic Keratosis is a skin condition characterized by rough, scaly patches on areas of the skin that have been exposed to the sun, such as the face or scalp. It occurs when skin cells are damaged by ultraviolet (UV) light, leading to abnormal growth. These patches can vary in color, appearing as red, pink, or brown, and may feel itchy or tender. Over time, the lesions can become thicker and more pronounced. While they are not cancerous, they have the potential to develop into skin cancer if left untreated. Actinic Keratosis is more common in fair-skinned individuals and those with a history of extensive sun exposure.

Trial ID:

2023-505487-11-00

Protocol code:

M-14867-33

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Tirbanibulin Ointment for Adults with Actinic Keratosis on the Face or Scalp

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