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

Conditions

Actinic Keratosis

Brief summary

Proportion of patients with histologically confirmed invasive SCC in the TF over the 3-year study period.

Detailed description

AEs and SAEs over 3 years, Proportion of patients with any other skin cancer (other than SCC) in the TF over the 3-year study period, Time to occurrence of invasive SCC from baseline in the TF., Proportion of patients requiring rescue treatment after 1 treatment course., Proportion of patients requiring rescue treatment at any time during the study., Proportion of patients with no lesions after treatment of the first recurrence with tirbanibulin during the first 52 weeks., Other safety assessments (vital signs, PE) over 3 years., Change from baseline in Skindex-16 overall and for all three domain scores (Symptoms, Emotions, and Functioning) by arm and by visit., Cosmetic outcome by arm and by visit., Treatment Satisfaction Questionnaire for Medication transformed scores by arm and by visit.

Related papers

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Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGKlisyri 10 mg/g ointment

DRUGSolaraze 30 mg/g Gel

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of patients with histologically confirmed invasive SCC in the TF over the 3-year study period.	—

Secondary

Measure	Time frame
AEs and SAEs over 3 years, Proportion of patients with any other skin cancer (other than SCC) in the TF over the 3-year study period, Time to occurrence of invasive SCC from baseline in the TF., Proportion of patients requiring rescue treatment after 1 treatment course., Proportion of patients requiring rescue treatment at any time during the study., Proportion of patients with no lesions after treatment of the first recurrence with tirbanibulin during the first 52 weeks., Other safety assessments (vital signs, PE) over 3 years., Change from baseline in Skindex-16 overall and for all three domain scores (Symptoms, Emotions, and Functioning) by arm and by visit., Cosmetic outcome by arm and by visit., Treatment Satisfaction Questionnaire for Medication transformed scores by arm and by visit.	—

Measure

Time frame

AEs and SAEs over 3 years, Proportion of patients with any other skin cancer (other than SCC) in the TF over the 3-year study period, Time to occurrence of invasive SCC from baseline in the TF., Proportion of patients requiring rescue treatment after 1 treatment course., Proportion of patients requiring rescue treatment at any time during the study., Proportion of patients with no lesions after treatment of the first recurrence with tirbanibulin during the first 52 weeks., Other safety assessments (vital signs, PE) over 3 years., Change from baseline in Skindex-16 overall and for all three domain scores (Symptoms, Emotions, and Functioning) by arm and by visit., Cosmetic outcome by arm and by visit., Treatment Satisfaction Questionnaire for Medication transformed scores by arm and by visit.

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Countries

France, Germany, Italy, Poland, Spain

Outcome results

None listed