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

Keratosis, Actinic Clinical Trial

Official title:

A Phase 4, Multi-centre, Randomized, Evaluator-blinded, Active-controlled Study to Determine the Incidence of Squamous Cell Carcinoma and Evaluate the Long-term Safety of Tirbanibulin 10 mg/g Ointment and Diclofenac Sodium 3% Gel for the Treatment of Adult Patients With Actinic Keratosis on the Face or Scalp

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05387525
• Other study ID #: M-14789-41
• Secondary ID: 2021-004349-18
• Status: Recruiting
• Phase: Phase 4
• Start date: October 24, 2022
• Est. completion date: March 2027

Study information

• Verified date: February 2024
• Source: Almirall, S.A.
• Contact: Tolga Baykal, Physician
• Phone: +34673560029
• Email: tolga.baykal[@]almirall.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
France	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
Germany	Almirall Investigational Site 205	Augsburg
Germany	Almirall Investigation Site 201	Bochum
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 207	Marburg
Germany	Almirall Investigational Site 209	Merzig
Germany	Almirall Investigation Site 202	Recklinghausen
Italy	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	Napoli
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
Poland	Almirall Investigational Site 27	Kraków
Poland	Almirall Investigational Site 403	Lublin
Poland	Almirall Investigational Site 26	Ostrowiec Swietokrzyski
Poland	Almirall Investigational Site 408	Rzeszów
Poland	Almirall Investigational Site 407	Warsaw
Poland	Almirall Investigational Site 401	Wroclaw
Poland	Almirall Investigational Site 402	Wroclaw
Spain	Almirall Investigational Site 502	Barcelona
Spain	Almirall Investigational Site 508	Barcelona
Spain	Almirall Investigational Site 507	Granada
Spain	Almirall Investigational Site 509	Granada
Spain	Almirall Investigational Site 503	Madrid
Spain	Almirall Investigational Site 504	Salamanca
Spain	Almirall Investigational Site 505	Sevilla
Spain	Almirall Investigational Site 506	Valence
Spain	Almirall Investigational Site 501	Zaragoza
United Kingdom	Almirall Investigational Site 709	Cardiff
United Kingdom	Almirall Investigational Site 703	London
United Kingdom	Almirall Investigational Site 708	Oxford
United Kingdom	Almirall Investigational Site 704	Poole
United Kingdom	Almirall Investigational Site 701	Salford
United Kingdom	Almirall Investigational Site 706	Weston-super-Mare

Sponsors (1)

Lead Sponsor	Collaborator
Almirall, S.A.

Countries where clinical trial is conducted

France,  Germany,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Histologically Confirmed Invasive Squamous Cell Carcinoma (SCC) in the Treatment Field (TF)	Percentage of participants with histologically confirmed invasive SCC in the TF will be reported as assessed by dermoscopy.	Up to 3 years
Secondary	Number of Participants With Adverse Events (AEs)	An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered an Investigational Product. An AE does not necessarily have a causal relationship with the medicinal product.	Up to 3 years
Secondary	Number of Participants With Serious Adverse Events (SAEs)	A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that at any dose, resulted in death, was life-threatening (i.e, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug).	Up to 3 years
Secondary	Percentage of Participants With any Other Skin Cancer (Other Than SCC) in the TF	Percentage of participants with any other skin cancer (other than SCC) in the TF will be reported.	Up to 3 years
Secondary	Time to Occurrence of Invasive SCC From Baseline in the TF	Time to occurrence of invasive SCC from baseline in the TF will be reported.	Up to 3 years
Secondary	Percentage of Participants Requiring Rescue Treatment After 1 Treatment Course	Percentage of participants requiring rescue treatment after 1 treatment course will be reported.	Up to 3 years
Secondary	Percentage of Participants Requiring Rescue Treatment at Any Time During the Study	Percentage of participants requiring rescue treatment at any time during the study will be reported.	Up to 3 years
Secondary	Percentage of Participants With no Lesions After Treatment of the First Recurrence With Tirbanibulin During the First 52 Weeks	Percentage of participants with no lesions after treatment of the first recurrence with tirbanibulin during the first 52 weeks will be reported.	Up to Week 52
Secondary	Number of Participants With Vital Signs Abnormalities	Number of participants with vital signs (including measurement of heart rate, respiratory rate, systolic and diastolic blood pressure and tympanic temperature) will be reported.	Up to 3 years
Secondary	Number of Participants With Physical Examination Abnormalities	Number of participants with physical examination abnormalities (height, weight and an assessment of head, eyes, ears, nose and throat, integumentary/dermatological, gastrointestinal, cardiovascular, respiratory, musculoskeletal, and neurological systems) will be reported.	Up to 3 years