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

NCT02404389 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2021-01-05

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Austria
  • Denmark
  • Germany
  • Iceland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02404389 on ClinicalTrials.gov