🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT05387525
Active, not recruiting Phase 4

A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp

NCT05387525 · tracked via the Priya Life Science UK tracker
Sponsor
Almirall, S.A.
Phase
Phase 4
Started
2022-10-24
Last updated
2025-02-11

Condition(s) studied

Keratosis, Actinic

Investigational drug(s) / intervention(s)

Tirbanibulin (Klisyri®) 10 mg/g ointmentDiclofenac Sodium 3% Gel

Tirbanibulin (Klisyri®) 10 mg/g ointment: Participants will apply tirbanibulin 10 mg/g ointment topically for 5 days over 25 cm\^2 of the face or scalp with Actinic Keratosis (AK).

Diclofenac Sodium 3% Gel: Participants will apply diclofenac dodium 3% gel twice daily for 60 to 90 days.

Study summary

The purpose of the study is to evaluate the incidence of biopsy confirmed invasive squamous cell carcinoma (SCC) in the selected treatment field (TF) after administration of topical tirbanibulin 10 milligram (mg)/gram (g) ointment or diclofenac sodium 3 percent (%) gel over the 3-year study period.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * A treatment field (TF) on the face or scalp (excluding lips, eyelids, ears, and inside the nostrils), that: a) is a contiguous area measuring 25 cm\^2, b) contains 2 to 8 clinically typical, visible, and discrete actinic keratosis (AK) lesions, and c) has an overall clinical picture that is consistent with Olsen grade 1 * If a women of child-bearing 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), she must: a) Have a negative urine pregnancy test using a highly sensitive method at screening and on Day 1 prior to treatment administration. b) Be using effective methods of birth control. c) Agree to have pregnancy tests while in the study and at the end of the study * Participants should be willing to avoid sunlight or ultraviolet (UV) light exposure, including the use of tanning beds, to the face or scalp during the study * Participants should have the ability to understand the purpose and risks of the study, willingness and ability to comply with the protocol, and provide written informed consent in accordance with institutional and regulatory guidelines Exclusion Criteria: * The location of the TF is: a) on any location other than the face or scalp. b) within 5 centimeters (cm) of an incompletely healed wound. c) Within 10 cm of a suspected basal cell carcinoma (BCC) or other neoplasm. d) on the lips, eyelids, ears, or inside the nostrils, periorbital, perioral, or the skin surrounding the nostrils * Presence in the TF of: a) clinically atypical and/or rapidly changing AK lesions b) hyperkeratotic or hypertrophic lesions, recalcitrant disease (had cryosurgery on 2 previous occasions), and/or cutaneous horn. c) confluent AK lesions (that is, non-discrete lesions, as per inclusion criterion 2). d) Persisting AK lesions at the screening visit following topical treatment with diclofenac sodium 3 percent (%) gel * History of any malignant skin tumour in the TF or history of skin tumour in any region of the body which has metastasized or in which metastasis within the study period is likely * History of any malignant tumour with systemic antitumor treatment (including radiotherapy) within 12 weeks prior to the Screening Visit or systemic antitumor treatment is expected while on the study * Immunocompromised participants, including participants with a history of chronic systemic lymphoma or chronic myeloid leukaemia, or organ transplant recipients

Primary outcome measure(s)

Trial sites (49)

FacilityCityRegionStatus
Almirall Investigation Site 102 Lille France
Almirall Investigation Site 103 Marseille France
Almirall Investigation Site 104 Nice France
Almirall Investigational Site 106 Paris France
Almirall Investigational Site 105 Rouen France
Almirall Investigational Site 101 Saint-Priest-en-Jarez France
Almirall Investigational Site 205 Augsburg Germany
Almirall Investigational Site 211 Bad Bentheim Germany
Almirall Investigation Site 201 Bochum Germany
Almirall Investigational Site 214 Bochum Germany
Almirall Investigational Site 212 Bonn Germany
Almirall Investigational Site 208 Detmold Germany
Almirall Investigational Site 210 Dresden Germany
Almirall Investigational Site 204 Erlangen Germany
Almirall Investigational Site 206 Hamburg Germany
Almirall Investigational Site 213 Hamburg Germany
Almirall Investigational Site 207 Marburg Germany
Almirall Investigational Site 209 Merzig Germany
Almirall Investigation Site 202 Recklinghausen Germany
Almirall Investigational Site 309 Arezzo Italy
Almirall Investigational Site 302 Brescia Italy
Almirall Investigational Site 304 Genova Italy
Almirall Investigational Site 308 Modena Italy
Almirall Investigational Site 301 Naples Italy
Almirall Investigational Site 303 Reggio Emilia Italy
Almirall Investigational Site 305 Roma Italy
Almirall Investigational Site 306 Roma Italy
Almirall Investigational Site 307 Roma Italy
Almirall Investigational Site 310 Rozzano Italy
Almirall Investigational Site 403 Lublin Poland
Almirall Investigational Site 406 Rzeszów Poland
Almirall Investigational Site 407 Warsaw Poland
Almirall Investigational Site 401 Wroclaw Poland
Almirall Investigational Site 402 Wroclaw Poland
Almirall Investigational Site 502 Barcelona Spain
Almirall Investigational Site 508 Barcelona Spain
Almirall Investigational Site 510 Barcelona Spain
Almirall Investigational Site 507 Granada Spain
Almirall Investigational Site 509 Granada Spain
Almirall Investigational Site 503 Madrid Spain

+ 9 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05387525 on ClinicalTrials.gov ↗ ← All trials in the UK