drugset / Trial / NCT02404389

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

NCT02404389 ↗

Phase 2 Completed 82 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2015-03-05
Primary completion
2016-01-27
Completion
2016-01-27

Outcome

Missed primary endpoint

registry LFX453 0.1% NMC vs Combined Vehicle; p = 0.515; Mean Difference (Net) 0.00 (90% CI -0.12 to 0.12) NCT02404389 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Imiquimod Other / unclassified — Topical
Subject LFX453 Unknown 0.1 % Topical
Subject LFX453 Unknown 0.15 % Topical

Indications