NCT02404389

Safety, Tolerability, and Efficacy Study of LFX453 in Actinic Keratosis Patients

A Randomized, Vehicle Controlled, Active Comparator, Parallel Group Study to Evaluate Safety, Tolerability and Preliminary Efficacy of Topical LFX453 Formulations in Patients With Actinic Keratosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	Investigational Treatment	Topical application for two treatment cycles with twice daily applications, separated by a 4 week treatment pause and followed by 8 week treatment free follow-up.
DRUG	Active comparator	Topical treatment with Aldara 3 times per week. The group will be open-label, but however blinded to the efficacy assessor, and followed by 8 week treatment free follow-up.

Timeline

• Start date: 2015-03-05
• Primary completion: 2016-01-27
• Completion: 2016-01-27
• First posted: 2015-03-31
• Last updated: 2021-01-05
• Results posted: 2018-03-19

Locations

10 sites across 5 countries: Austria, Denmark, Germany, Iceland, United Kingdom