Clinical Trial: Safety, Tolerability, and Efficacy Study of LFX453 in Actinic Keratosis Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Vehicle Controlled, Active Comparator, Parallel Group Study to Evaluate Safety, Tolerability and Preliminary Efficacy of Topical LFX453 Formulations in Patients With Actinic
Brief Summary: This is a randomized, vehicle controlled, active comparator, parallel group, study with a total duration of 24 weeks including screening and follow-up. Study drug is applied topically for 2 cycles of 4 week treatment, separated by 4 weeks off-treatment. Assessors of study endpoints are blinded to treatment allocation.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome:
- Number of adverse events and local tolerability assessment scores as a measure of safety and tolerability [ Time Frame: 20 weeks ]
- Efficacy of LFX453 compared to vehicle as measured by lesion count [ Time Frame: 20 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Concentration of LFX453 in skin samples and blood samples after application [ Time Frame: 12 weeks ]
- Efficacy of LFX453 compared to vehicle at week 8 and week 16 as measured by lesion count [ Time Frame: 16 weeks ]
Original Secondary Outcome: Same as current
Information By: Novartis
Dates:
Date Received: January 23, 2015
Date Started: March 2015
Date Completion:
Last Updated: August 8, 2016
Last Verified: August 2016
