Clinical trial NCT05387525: A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Keratosis, Actinic
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2022-05-24
Enrollment: 447
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Percentage of Participants with Histologically Confirmed Invasive Squamous Cell Carcinoma (SCC) in the Treatment Field (TF)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 3 years
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to 3 years
measure: Percentage of Participants With any Other Skin Cancer (Other Than SCC) in the TF
timeFrame: Up to 3 years
measure: Time to Occurrence of Invasive SCC From Baseline in the TF
timeFrame: Up to 3 years
measure: Percentage of Participants Requiring Rescue Treatment After 1 Treatment Course
timeFrame: Up to 3 years
measure: Percentage of Participants Requiring Rescue Treatment at Any Time During the Study
timeFrame: Up to 3 years
measure: Percentage of Participants With no Lesions After Treatment of the First Recurrence With Tirbanibulin During the First 52 Weeks
timeFrame: Up to Week 52
measure: Number of Participants With Vital Signs Abnormalities
timeFrame: Up to 3 years
measure: Number of Participants With Physical Examination Abnormalities
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Lille
country: France
facility: Almirall Investigation Site 102
city: Marseille
country: France
facility: Almirall Investigation Site 103
city: Nice
country: France
facility: Almirall Investigation Site 104
city: Paris
country: France
facility: Almirall Investigational Site 106
city: Rouen
country: France
facility: Almirall Investigational Site 105
city: Saint-Priest-en-Jarez
country: France
facility: Almirall Investigational Site 101
city: Augsburg
country: Germany
facility: Almirall Investigational Site 205
city: Bad Bentheim
country: Germany
facility: Almirall Investigational Site 211
city: Bochum
country: Germany
facility: Almirall Investigation Site 201
city: Bochum
country: Germany
facility: Almirall Investigational Site 214
city: Bonn
country: Germany
facility: Almirall Investigational Site 212
city: Detmold
country: Germany
facility: Almirall Investigational Site 208
city: Dresden
country: Germany
facility: Almirall Investigational Site 210
city: Erlangen
country: Germany
facility: Almirall Investigational Site 204
city: Hamburg
country: Germany
facility: Almirall Investigational Site 206
city: Hamburg
country: Germany
facility: Almirall Investigational Site 213
city: Marburg
country: Germany
facility: Almirall Investigational Site 207
city: Merzig
country: Germany
facility: Almirall Investigational Site 209
city: Recklinghausen
country: Germany
facility: Almirall Investigation Site 202
city: Arezzo
country: Italy
facility: Almirall Investigational Site 309
city: Brescia
country: Italy
facility: Almirall Investigational Site 302
city: Genova
country: Italy
facility: Almirall Investigational Site 304
city: Modena
country: Italy
facility: Almirall Investigational Site 308
city: Napoli
country: Italy
facility: Almirall Investigational Site 301
city: Reggio Emilia
country: Italy
facility: Almirall Investigational Site 303
city: Roma
country: Italy
facility: Almirall Investigational Site 305
city: Roma
country: Italy
facility: Almirall Investigational Site 306
city: Roma
country: Italy
facility: Almirall Investigational Site 307
city: Rozzano
country: Italy
facility: Almirall Investigational Site 310
city: Lublin
country: Poland
facility: Almirall Investigational Site 403
city: Rzeszów
country: Poland
facility: Almirall Investigational Site 406
city: Warsaw
country: Poland
facility: Almirall Investigational Site 407
city: Wrocław
country: Poland
facility: Almirall Investigational Site 401
city: Wrocław
country: Poland
facility: Almirall Investigational Site 402
city: Barcelona
country: Spain
facility: Almirall Investigational Site 502
city: Barcelona
country: Spain
facility: Almirall Investigational Site 508
city: Barcelona
country: Spain
facility: Almirall Investigational Site 510
city: Granada
country: Spain
facility: Almirall Investigational Site 507
city: Granada
country: Spain
facility: Almirall Investigational Site 509
city: Madrid
country: Spain
facility: Almirall Investigational Site 503
city: Salamanca
country: Spain
facility: Almirall Investigational Site 504
city: Sevilla
country: Spain
facility: Almirall Investigational Site 505
city: Valence
country: Spain
facility: Almirall Investigational Site 506
city: Zaragoza
country: Spain
facility: Almirall Investigational Site 501
city: London
country: United Kingdom
facility: Almirall Investigational Site 703
city: London
country: United Kingdom
facility: Almirall Investigational Site 709
city: Oxford
country: United Kingdom
facility: Almirall Investigational Site 708
city: Poole
country: United Kingdom
facility: Almirall Investigational Site 704
city: Weston-super-Mare
country: United Kingdom
facility: Almirall Investigational Site 706
Study officials:
References: