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
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
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)
- Percentage of Participants with Histologically Confirmed Invasive Squamous Cell Carcinoma (SCC) in the Treatment Field (TF) — Up to 3 years
Percentage of participants with histologically confirmed invasive SCC in the TF will be reported as assessed by dermoscopy.
Trial sites (49)
| Facility | City | Region | Status |
| 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.