MedTrace Logo

Efficacy and Safety of Ingenol Mebutate Gel 0.015% Compared to Diclofenac Sodium Gel 3% in Subjects With Actinic Keratoses on the Face or Scalp

NCT02406014 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 502

Last updated 2025-02-24

No results posted yet for this study

Summary

This is a phase 4, multi-centre, randomized, two group, open label, active controlled, parallel group, 17 week trial.

Conditions

  • Actinic Keratosis (AK)

Interventions

DRUG

Ingenol Mebutate Gel, 0.015%

Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs.

DRUG

Diclofenac sodium gel 3%

Diclofenac sodium gel 3% Solaraze® applied on the selected treatment area, twice daily for 90 days.

Sponsors & Collaborators

  • LEO Pharma

    lead INDUSTRY

Principal Investigators

  • Eggert Stockfleth, Prof.Dr.med. · St. Josef-Hospital im Katholischen Klinikum Bochum

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Germany

Study Locations

More Related Trials

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 NCT02406014 on ClinicalTrials.gov