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

Primary Purpose

Keratosis, Actinic

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Tirbanibulin (Klisyri®) 10 mg/g ointment
Diclofenac Sodium 3% Gel
Sponsored by
Almirall, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratosis, Actinic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Almirall Investigation Site 102
  • Almirall Investigation Site 103
  • Almirall Investigation Site 104
  • Almirall Investigational Site 106
  • Almirall Investigational Site 101
  • Almirall Investigational Site 205
  • Almirall Investigation Site 201
  • Almirall Investigational Site 208
  • Almirall Investigational Site 210
  • Almirall Investigational Site 204
  • Almirall Investigational Site 206
  • Almirall Investigational Site 207
  • Almirall Investigational Site 209
  • Almirall Investigation Site 202
  • Almirall Investigational Site 309
  • Almirall Investigational Site 302
  • Almirall Investigational Site 304
  • Almirall Investigational Site 308
  • Almirall Investigational Site 301
  • Almirall Investigational Site 303
  • Almirall Investigational Site 305
  • Almirall Investigational Site 306
  • Almirall Investigational Site 307
  • Almirall Investigational Site 310
  • Almirall Investigational Site 27
  • Almirall Investigational Site 403
  • Almirall Investigational Site 26
  • Almirall Investigational Site 408
  • Almirall Investigational Site 407
  • Almirall Investigational Site 401
  • Almirall Investigational Site 402
  • Almirall Investigational Site 502
  • Almirall Investigational Site 508
  • Almirall Investigational Site 507
  • Almirall Investigational Site 509
  • Almirall Investigational Site 503Recruiting
  • Almirall Investigational Site 504
  • Almirall Investigational Site 505
  • Almirall Investigational Site 506
  • Almirall Investigational Site 501
  • Almirall Investigational Site 709
  • Almirall Investigational Site 703
  • Almirall Investigational Site 708
  • Almirall Investigational Site 704
  • Almirall Investigational Site 701
  • Almirall Investigational Site 706

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tirbanibulin 10 milligram per gram (mg/g) ointment

Diclofenac Sodium 3% Gel

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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.
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.
Percentage of Participants Requiring Rescue Treatment After 1 Treatment Course
Percentage of participants requiring rescue treatment after 1 treatment course will be reported.
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.
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.
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.
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.

Full Information

First Posted
May 19, 2022
Last Updated
November 3, 2022
Sponsor
Almirall, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT05387525
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2022 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Almirall, S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratosis, Actinic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
540 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tirbanibulin 10 milligram per gram (mg/g) ointment
Arm Type
Experimental
Arm Description
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.
Arm Title
Diclofenac Sodium 3% Gel
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tirbanibulin (Klisyri®) 10 mg/g ointment
Other Intervention Name(s)
Klisyri®
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Diclofenac Sodium 3% Gel
Intervention Description
Participants will apply diclofenac dodium 3% gel twice daily for 60 to 90 days.
Primary Outcome Measure Information:
Title
Percentage of Participants with Histologically Confirmed Invasive Squamous Cell Carcinoma (SCC) in the Treatment Field (TF)
Description
Percentage of participants with histologically confirmed invasive SCC in the TF will be reported as assessed by dermoscopy.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs)
Description
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.
Time Frame
Up to 3 years
Title
Number of Participants With Serious Adverse Events (SAEs)
Description
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).
Time Frame
Up to 3 years
Title
Percentage of Participants With any Other Skin Cancer (Other Than SCC) in the TF
Description
Percentage of participants with any other skin cancer (other than SCC) in the TF will be reported.
Time Frame
Up to 3 years
Title
Time to Occurrence of Invasive SCC From Baseline in the TF
Description
Time to occurrence of invasive SCC from baseline in the TF will be reported.
Time Frame
Up to 3 years
Title
Percentage of Participants Requiring Rescue Treatment After 1 Treatment Course
Description
Percentage of participants requiring rescue treatment after 1 treatment course will be reported.
Time Frame
Up to 3 years
Title
Percentage of Participants Requiring Rescue Treatment at Any Time During the Study
Description
Percentage of participants requiring rescue treatment at any time during the study will be reported.
Time Frame
Up to 3 years
Title
Percentage of Participants With no Lesions After Treatment of the First Recurrence With Tirbanibulin During the First 52 Weeks
Description
Percentage of participants with no lesions after treatment of the first recurrence with tirbanibulin during the first 52 weeks will be reported.
Time Frame
Up to Week 52
Title
Number of Participants With Vital Signs Abnormalities
Description
Number of participants with vital signs (including measurement of heart rate, respiratory rate, systolic and diastolic blood pressure and tympanic temperature) will be reported.
Time Frame
Up to 3 years
Title
Number of Participants With Physical Examination Abnormalities
Description
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.
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vera Kiyasova, Physician
Phone
+34 673873989
Email
vera.kiyasova@almirall.com
First Name & Middle Initial & Last Name or Official Title & Degree
Diego Herrera
Phone
932913482
Email
diego.herrera@almirall.com
Facility Information:
Facility Name
Almirall Investigation Site 102
City
Lille
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigation Site 103
City
Marseille
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigation Site 104
City
Nice
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 106
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 101
City
Saint-Priest-en-Jarez
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 205
City
Augsburg
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigation Site 201
City
Bochum
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 208
City
Detmold
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 210
City
Dresden
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 204
City
Erlangen
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 206
City
Hamburg
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Almirall Investigational Site 207
City
Marburg
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alm S 25
Facility Name
Almirall Investigational Site 209
City
Merzig
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Almirall Investigation Site 202
City
Recklinghausen
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 309
City
Arezzo
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 302
City
Brescia
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 304
City
Genova
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 308
City
Modena
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 301
City
Napoli
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 303
City
Reggio Emilia
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 305
City
Roma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 306
City
Roma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 307
City
Roma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 310
City
Rozzano
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 27
City
Kraków
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 403
City
Lublin
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 26
City
Ostrowiec Świętokrzyski
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 408
City
Rzeszów
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 407
City
Warsaw
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Almirall Investigational Site 401
City
Wrocław
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Almirall Investigational Site 402
City
Wrocław
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Almirall Investigational Site 502
City
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 508
City
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 507
City
Granada
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 509
City
Granada
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 503
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Almirall Investigational Site 504
City
Salamanca
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Almirall Investigational Site 505
City
Sevilla
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 506
City
Valence
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Almirall Investigational Site 501
City
Zaragoza
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 709
City
Cardiff
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 703
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 708
City
Oxford
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 704
City
Poole
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 701
City
Salford
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Almirall Investigational Site 706
City
Weston-super-Mare
Country
United Kingdom
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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