M-14789-41

• Research type

  Research Study

• Full title

  A Phase 4, Multi-centre, Randomized, Evaluatorblinded, 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

• IRAS ID

  1005448

• Contact name

  Natalia Fernández

• Contact email

  gco@almirall.com

• Sponsor organisation

  Almirall, S.A.

• Eudract number

  2021-004349-18

• Clinicaltrials.gov Identifier

  NCT05387525

• Research summary

  This is a research study funded by Almirall, S.A to evaluate tirbanibulin as a treatment for actinic keratosis.

  Patients with actinic keratosis generally show multiple rough, scaly spots of skin (lesions) in areas which have been exposed to sunlight for a long time. A low percentage of lesions (up to 6 out of 1000 per year) can progress to a slow-growing skin cancer (squamous cell carcinoma or SCC) which can spread to other parts of the body. Therefore, the goal of actinic keratosis treatment is to eliminate skin lesions to reduce the risk of SCC.

  Tirbanibulin is currently marketed in Europe for the treatment of actinic keratosis. It is a topical medicine, which means it has to be applied on skin, and is currently approved for the treatment of limited areas (25 cm2) of the face or scalp containing actinic keratosis lesions. Tirbanibulin works by killing fast-growing cells, such as the abnormal cells present in these lesions. The main purpose of this study is to follow the progress of skin areas affected by actinic keratosis when treated with tirbanibulin or an alternative medicine, diclofenac sodium, to record the occurrence of SCC. Diclofenac will be tested along tirbanibulin as it is widely used in Europe as topical medicine for actinic keratosis
  The study will also investigate the safety of tirbanibulin and diclofenac, how efficacious they are when treating new/reappeared lesions, and their effect on quality of life and skin appearance, as well as patients’ satisfaction with these medicines.

  About 540 people with actinic keratosis lesions on their face or scalp will join the study at centres across the UK and Europe. Their participation in the study will last approximately 3 years and involve 12 planned visits to the study centre and three phone calls.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  22/EM/0131

• Date of REC Opinion

  1 Aug 2022

• REC opinion

  Further Information Favourable Opinion