Study on the Safety of Tirbanibulin and Diclofenac Sodium 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 the treatment of Actinic Keratosis, a skin condition that appears as rough, scaly patches on the skin, often due to sun exposure. The study will use two treatments: Tirbanibulin 10 mg/g ointment, also known by its code name KX-01, and Diclofenac Sodium 3% gel, marketed as Solaraze. These treatments are applied to the skin to help manage the condition.

The purpose of the study is to determine the occurrence of a type of skin cancer called Squamous Cell Carcinoma and to evaluate the long-term safety of these treatments in adults with actinic keratosis on the face or scalp. Participants will be randomly assigned to use either tirbanibulin ointment or diclofenac gel. The study will last for three years, during which the safety and effectiveness of the treatments will be monitored.

Throughout the study, participants will apply the treatment to the affected area on their face or scalp. The tirbanibulin ointment is used for a short period of five days, while the diclofenac gel is used for a longer period of up to 90 days. The study aims to provide valuable information on the safety of these treatments and their ability to prevent the development of squamous cell carcinoma in patients with actinic keratosis.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age and the presence of actinic keratosis on the face or scalp.

A test field (TF) is identified, which is a 25 cm² area containing 2 to 8 visible lesions.

2 treatment administration

The treatment involves the application of either tirbanibulin 10 mg/g ointment or diclofenac sodium 3% gel.

Both medications are applied to the skin (cutaneous use) on the affected area as per the study protocol.

3 treatment duration

The treatment is administered over a period of 3 years, with regular monitoring and assessments.

4 monitoring and assessments

Regular assessments are conducted to monitor the incidence of squamous cell carcinoma (SCC) and other skin conditions.

Safety assessments, including vital signs and physical examinations, are performed throughout the study.

5 end of study

The study concludes with a final assessment to evaluate the long-term safety and effectiveness of the treatment.

The estimated end date for the study is July 31, 2027.

Who Can Join the Study?

Must be a male or female who is 18 years old or older.
Must have a treatment field (TF) on the face or scalp, but not on the lips, eyelids, ears, or inside the nostrils. This area should:
- Be a connected area measuring 25 square centimeters.
- Contain 2 to 8 visible and separate actinic keratosis (AK) lesions. AK lesions are rough, scaly patches on the skin caused by sun exposure.
- Have a clinical appearance that matches Olsen grade 1, which is a way to describe the severity of the skin condition.
If a woman of childbearing potential, meaning she is fertile, she must:
- Have a negative pregnancy test at the start and before treatment.
- Use effective birth control methods during the study.
- Agree to have pregnancy tests during and at the end of the study.
Must be willing to avoid sunlight or UV light exposure to the face or scalp during the study, including avoiding tanning beds.
Must be able to understand the purpose and risks of the study, be willing and able to follow the study rules, and provide written informed consent. This means agreeing to participate after being informed about the study details.

Who Cannot Join the Study?

Patients who have a history of skin cancer other than Actinic Keratosis cannot participate. Actinic Keratosis is a rough, scaly patch on the skin caused by sun exposure.
Patients who are currently using other treatments for Actinic Keratosis are not eligible.
Patients with a known allergy to the study medications, such as tirbanibulin or diclofenac, cannot join the study.
Patients who are pregnant or breastfeeding are excluded from participating.
Patients who have participated in another clinical trial within the last 30 days are not eligible.
Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Universitaire De Lille	Lille	France
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy
Royalderm Agnieszka Nawrocka	Warsaw	Poland

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Katholisches Klinikum Bochum gGmbH	Bochum	Germany
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Dr. Niesmann And Dr. Othlinghaus GbR	Bochum	Germany
Tagast 41	Nice	France
Dermatologikum Hamburg GmbH	Hamburg	Germany
Hms GmbH	Merzig	Germany
Universita’ Degli Studi Di Modena E Reggio Emilia	Modena	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie	Rzeszow	Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.	Wroclaw	Poland
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Hospital Clinic De Barcelona	Barcelona	Spain
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Azienda USL Toscana Sud Est	Arezzo	Italy
Hopital Beaujon	Clichy	France
Koohufzg Lrcss Gnmc	Detmold	Germany
Uimvwpefde Daysu Setsi Dx Rfjk Lr Stbzuijv	Rome	Italy
Uqbmcyfrnrshewzilgner Acumfugv	Augsburg	Germany
Thbyofttmsi uiv Swuufkahffh Bewnupla Gqkl	Bad Bentheim	Germany
Dgfdk Sglpptk Ggms	Hamburg	Germany
Kqhggote Vknb Gfkv	Recklinghausen	Germany
Alnmcbqvwt Pqwayglt Hvpnzqlp Dp Mjxzwcpuq	Marseille	France
Giobuydttckuxayd Zovhzox Bruk	Bonn	Germany
Aomguxc Unz Ipael De Rbndqq Eeupsr	Reggio Emilia	Italy
Dgrufczgjn Ssu z olww	Wroclaw	Poland
Hrerdnir Uajkblgznnetv Hizaqvwr Tiosc y Pbcevz Iegmdjij Cxnknp dmocaypvqlnggtkah (nvwq	Badalona	Spain
Lcgflno Symzabywlourxon Gazruqz Dzfcgncekwwtinx	Lublin	Poland
Itupifmz dh Cuqcysedwqef Hbdskzmpdhe Uwmzqwngojmii df Stwrp Ecmmwct (cgrqfxh	Saint Priest En Jarez	France
Hprrpfqp Vdmd dgmpxnwd	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	24.10.2022
Germany	Not recruiting	24.10.2022
Italy	Not recruiting	24.10.2022
Poland	Not recruiting	24.10.2022
Spain	Not recruiting	24.10.2022

Trial locations

Investigated drugs:

Tirbanibulin is an ointment used in this study to treat actinic keratosis, a skin condition that can lead to squamous cell carcinoma. It is applied directly to the affected areas on the face or scalp. The study aims to assess the long-term safety of this medication and its effectiveness in preventing the development of skin cancer.

Diclofenac Sodium is a gel used in this study as an active treatment for actinic keratosis. It is applied to the skin to help reduce the risk of developing squamous cell carcinoma. The study compares the safety and effectiveness of this gel with the ointment to determine which is better at preventing skin cancer over a long period.

Investigated diseases:

Actinic keratosis

Actinic Keratosis – Actinic Keratosis is a skin condition characterized by rough, scaly patches on the skin, primarily caused by prolonged exposure to the sun. These patches are often found on areas such as the face, ears, lips, back of the hands, forearms, scalp, or neck. The condition progresses slowly and can sometimes develop into squamous cell carcinoma, a type of skin cancer, if left untreated. The patches may be red, pink, or brown and can feel dry or like sandpaper. Actinic Keratosis is more common in fair-skinned individuals and those who have spent a lot of time outdoors. Regular monitoring and protection from further sun exposure are important to manage the condition.

Trial ID:

2024-514394-22-00

Protocol code:

M-14789-41

NCT ID:

NCT05387525

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety of Tirbanibulin and Diclofenac Sodium for Adults with Actinic Keratosis on the Face or Scalp

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?