Keratosis, ActinicPhase 4AKtiveNCT05387525
A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp
A Phase 4 study testing Tirbanibulin (Klisyri®) 10 mg/g ointment and Diclofenac Sodium 3% Gel in people with Keratosis, Actinic, run by Almirall, S.A. at 49 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratosis, Actinic
- What is being tested?
- Tirbanibulin (Klisyri®) 10 mg/g ointment and Diclofenac Sodium 3% Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 447 participants
- Where
- 49 sitesin 6 countries
- Study dates
- 24 Oct 2022to Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
49 sites in 6 countries.
49 sites in 6 countries
Germany13 sites
Almirall Investigational Site 205
Augsburg
Almirall Investigational Site 211
Bad Bentheim
Almirall Investigation Site 201
Bochum
Almirall Investigational Site 214
Bochum
Almirall Investigational Site 212
Bonn
Almirall Investigational Site 208
Detmold
Almirall Investigational Site 210
Dresden
Almirall Investigational Site 204
Erlangen
Almirall Investigational Site 206
Hamburg
Almirall Investigational Site 213
Hamburg
Almirall Investigational Site 207
Marburg
Almirall Investigational Site 209
Merzig
Almirall Investigation Site 202
Recklinghausen
Italy10 sites
Almirall Investigational Site 309
Arezzo
Almirall Investigational Site 302
Brescia
Almirall Investigational Site 304
Genova
Almirall Investigational Site 308
Modena
Almirall Investigational Site 301
Naples
Almirall Investigational Site 303
Reggio Emilia
Almirall Investigational Site 305
Roma
Almirall Investigational Site 306
Roma
Almirall Investigational Site 307
Roma
Almirall Investigational Site 310
Rozzano
Spain10 sites
Almirall Investigational Site 502
Barcelona
Almirall Investigational Site 508
Barcelona
Almirall Investigational Site 510
Barcelona
Almirall Investigational Site 507
Granada
Almirall Investigational Site 509
Granada
Almirall Investigational Site 503
Madrid
Almirall Investigational Site 504
Salamanca
Almirall Investigational Site 505
Seville
Almirall Investigational Site 506
Valencia
Almirall Investigational Site 501
Zaragoza
France6 sites
Almirall Investigation Site 102
Lille
Almirall Investigation Site 103
Marseille
Almirall Investigation Site 104
Nice
Almirall Investigational Site 106
Paris
Almirall Investigational Site 105
Rouen
Almirall Investigational Site 101
Saint-Priest-en-Jarez
Poland5 sites
Almirall Investigational Site 403
Lublin
Almirall Investigational Site 406
Rzeszów
Almirall Investigational Site 407
Warsaw
Almirall Investigational Site 401
Wroclaw
Almirall Investigational Site 402
Wroclaw
United Kingdom5 sites
Almirall Investigational Site 703
London
Almirall Investigational Site 709
London
Almirall Investigational Site 708
Oxford
Almirall Investigational Site 704
Poole
Almirall Investigational Site 706
Weston-super-Mare
About this study
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
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.
- Conditions
- Keratosis, Actinic
- Being tested
- Tirbanibulin (Klisyri®) 10 mg/g ointment, Diclofenac Sodium 3% Gel
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tirbanibulin (Klisyri®) 10 mg/g ointmentDrug
Also called Klisyri®
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% GelDrug
Participants will apply diclofenac dodium 3% gel twice daily for 60 to 90 days.
| Study group | Role | What they receive |
|---|---|---|
| Tirbanibulin 10 milligram per gram (mg/g) ointment | Experimental | Participants will apply tirbanibulin ointment 10 mg/g once daily to the treatment field (TF) for 5 consecutive days beginning Day 1. At subsequent visits, participants will have the option of an additional 5-day course(s) (with at least 16 weeks between starting date of treatment courses) at the discretion of the investigator if actinic keratosis (AK) lesions are present in the TF and physical treatment is not appropriate. Receives: Drug: Tirbanibulin (Klisyri®) 10 mg/g ointment |
| Diclofenac Sodium 3% Gel | Active comparator | Participants will apply diclofenac sodium 3% gel twice daily to the TF for 60 to 90 days beginning Day 1, with the option of further courses every 6 months (with at least 6 months between starting date of treatment courses) if lesions are found to be present in the TF at follow up visits and physical treatment is not appropriate. Receives: Drug: Diclofenac Sodium 3% Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 years
Secondary outcomes (9)
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.
Measured: Up to 3 years
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).
Measured: Up to 3 years
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.
Measured: Up to 3 years
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.
Measured: Up to 3 years
Percentage of Participants Requiring Rescue Treatment After 1 Treatment Course
Percentage of participants requiring rescue treatment after 1 treatment course will be reported.
Measured: Up to 3 years
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.
Measured: Up to 3 years
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.
Measured: Up to Week 52
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.
Measured: Up to 3 years
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.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start24 Oct 2022
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratosis, ActinicStudies of the same condition, open and under way.
- More trials run by Almirall, S.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 447 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387525
- Sponsor's protocol ID
- M-14789-41
- Other IDs
- 2021-004349-18
- Acronym
- AKtive
- Status last verified
- Feb 2025
- First submitted
- 19 May 2022
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05387525
- Acronym / sponsor ID
- AKtive / M-14789-41
- Conditions
- Keratosis, Actinic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 447 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirbanibulin 10 milligram per gram (mg/g) ointment | Experimental | Drug: Tirbanibulin (Klisyri®) 10 mg/g ointmentParticipants will apply tirbanibulin ointment 10 mg/g once daily to the treatment field (TF) for 5 consecutive days beginning Day 1. At subsequent visits, participants will have the option of an additional 5-day course(s) (with at least 16 weeks between starting date of treatment courses) at the discretion of the investigator if actinic keratosis (AK) lesions are present in the TF and physical treatment is not appropriate. |
| Diclofenac Sodium 3% Gel | Active comparator | Drug: Diclofenac Sodium 3% GelParticipants will apply diclofenac sodium 3% gel twice daily to the TF for 60 to 90 days beginning Day 1, with the option of further courses every 6 months (with at least 6 months between starting date of treatment courses) if lesions are found to be present in the TF at follow up visits and physical treatment is not appropriate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tirbanibulin (Klisyri®) 10 mg/g ointmentAlso: Klisyri®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). | Drug | Tirbanibulin 10 milligram per gram (mg/g) ointment |
| Diclofenac Sodium 3% GelParticipants will apply diclofenac dodium 3% gel twice daily for 60 to 90 days. | Drug | Diclofenac Sodium 3% Gel |
Primary outcome
Percentage of Participants with Histologically Confirmed Invasive Squamous Cell Carcinoma (SCC) in the Treatment Field (TF)
Time frame: Up to 3 years
Percentage of participants with histologically confirmed invasive SCC in the TF will be reported as assessed by dermoscopy.
9 secondary outcomes
Number of Participants With Adverse Events (AEs)
Time frame: Up to 3 years
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to 3 years
Percentage of Participants With any Other Skin Cancer (Other Than SCC) in the TF
Time frame: Up to 3 years
Time to Occurrence of Invasive SCC From Baseline in the TF
Time frame: Up to 3 years
Percentage of Participants Requiring Rescue Treatment After 1 Treatment Course
Time frame: Up to 3 years
Percentage of Participants Requiring Rescue Treatment at Any Time During the Study
Time frame: Up to 3 years
Percentage of Participants With no Lesions After Treatment of the First Recurrence With Tirbanibulin During the First 52 Weeks
Time frame: Up to Week 52
Number of Participants With Vital Signs Abnormalities
Time frame: Up to 3 years
Number of Participants With Physical Examination Abnormalities
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Keratosis, Actinic
Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Netherton Syndrome
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Actinic Keratosis
Active, not recruitingPhase 3
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Multiple Actinic Keratoses
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
49 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tirbanibulin (Klisyri®) 10 mg/g ointment and Diclofenac Sodium 3% Gel in people with Keratosis, Actinic, run by Almirall, S.A. at 49 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Germany, Italy, Spain, France, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Histologically Confirmed Invasive Squamous Cell Carcinoma (SCC) in the Treatment Field (TF) (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.