CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 82 enrolled
Drug / intervention
Investigational Treatment +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02404389
NCT02404389Phase 2Completed

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

Novartis Pharmaceuticals·interventional·Posted Mar 31, 2015·Updated Jan 5, 2021

In Brief

A Phase 2 clinical trial evaluating Investigational Treatment and Active comparator for Actinic Keratosis. Completed, enrolled 82 participants across 10 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Denmark, Germany, Iceland, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 31, 2015
Enrollment StartMar 5, 2015
Primary CompletionJan 27, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.3 years ago

Interventions

Investigational Treatmentdrug

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.

Active comparatordrug

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.