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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT05387525

Studienbeginn:
Oktober 2022

Letztes Update:
06.02.2024

Wirkstoff:
Tirbanibulin (Klisyri®) 10 mg/g ointment, Diclofenac Sodium 3% Gel

Indikation (Clinical Trials):
Keratosis, Actinic, Keratosis

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 4

Sponsor:
Almirall, S.A.

Collaborator:
-

Kontakt

Studienlocations
(3 von 47)

Almirall Investigational Site 205
Augsburg
(Bayern)
GermanyRekrutierend» Google-Maps
Almirall Investigation Site 201
Bochum
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Almirall Investigational Site 208
Detmold
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Almirall Investigational Site 210
Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Almirall Investigational Site 204
Erlangen
(Bayern)
GermanyRekrutierend» Google-Maps
Almirall Investigational Site 206
Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Almirall Investigational Site 209
Merzig
(Saarland)
GermanyRekrutierend» Google-Maps
Almirall Investigation Site 202
Recklinghausen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Almirall Investigational Site 101
Saint-Priest-en-Jarez
FranceRekrutierend» Google-Maps
Almirall Investigational Site 303
Reggio Emilia
ItalyRekrutierend» Google-Maps
Almirall Investigational Site 27
Kraków
PolandNoch nicht rekrutierend» Google-Maps
Almirall Investigational Site 26
Ostrowiec Świętokrzyski
PolandNoch nicht rekrutierend» Google-Maps
Almirall Investigational Site 709
Cardiff
United KingdomRekrutierend» Google-Maps
Almirall Investigational Site 703
London
United KingdomRekrutierend» Google-Maps
Almirall Investigational Site 708
Oxford
United KingdomRekrutierend» Google-Maps
Almirall Investigational Site 704
Poole
United KingdomRekrutierend» Google-Maps
Almirall Investigational Site 701
Salford
United KingdomNoch nicht rekrutierend» Google-Maps
Almirall Investigational Site 706
Weston-super-Mare
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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.



Secondary outcome:

1. Number of Participants With Adverse Events (AEs) (Time Frame - Up to 3 years):
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.

2. Number of Participants With Serious Adverse Events (SAEs) (Time Frame - Up to 3 years):
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).

3. Percentage of Participants With any Other Skin Cancer (Other Than SCC) in the TF (Time Frame - Up to 3 years):
Percentage of participants with any other skin cancer (other than SCC) in the TF will be reported.

4. Time to Occurrence of Invasive SCC From Baseline in the TF (Time Frame - Up to 3 years):
Time to occurrence of invasive SCC from baseline in the TF will be reported.

5. Percentage of Participants Requiring Rescue Treatment After 1 Treatment Course (Time Frame - Up to 3 years):
Percentage of participants requiring rescue treatment after 1 treatment course will be reported.

6. Percentage of Participants Requiring Rescue Treatment at Any Time During the Study (Time Frame - Up to 3 years):
Percentage of participants requiring rescue treatment at any time during the study will be reported.

7. 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):
Percentage of participants with no lesions after treatment of the first recurrence with tirbanibulin during the first 52 weeks will be reported.

8. Number of Participants With Vital Signs Abnormalities (Time Frame - Up to 3 years):
Number of participants with vital signs (including measurement of heart rate, respiratory rate, systolic and diastolic blood pressure and tympanic temperature) will be reported.

9. Number of Participants With Physical Examination Abnormalities (Time Frame - Up to 3 years):
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.

Studien-Arme

  • Experimental: Tirbanibulin 10 milligram per gram (mg/g) ointment
    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.
  • Active Comparator: Diclofenac Sodium 3% Gel
    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.

Geprüfte Regime

  • Tirbanibulin (Klisyri®) 10 mg/g ointment (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% Gel:
    Participants will apply diclofenac dodium 3% gel twice daily for 60 to 90 days.

Quelle: ClinicalTrials.gov


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