NCT02406014

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 502 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

All subjects who qualify for this trial are to have 4 to 8 clinically typical, visible and discrete AK lesions within a contiguous 25 cm2 treatment area on the face or scalp. Eligible subjects will be randomised in a 1:1 ratio to the following treatment groups: * Treatment Group A: Ingenol mebutate gel 0.015%, once daily for 3 consecutive days for the first treatment course. At 8 weeks after treatment initiation, subjects who present with existing AKs or newly emergent AKs in the treatment area will receive one more treatment course of ingenol mebutate gel 0.015%, daily for 3 consecutive days. * Treatment Group B: Diclofenac sodium gel 3%, (0.5 grams), twice daily for 90 days.

Conditions

• Actinic Keratosis (AK)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-04-01
• Last updated: 2025-02-24

Locations

1 site across 1 country: Germany