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

Phase 4

Completed

• Conditions: Actinic Keratosis (AK)
• Interventions: Drug: Diclofenac sodium gel 3%; Drug: Ingenol Mebutate Gel, 0.015%

• Registration Number: NCT02406014
• Lead Sponsor: LEO Pharma

Brief 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.

Study Timeline

• Study First Submitted: 2015-03-27
• Study First Submitted QC: 2015-03-31
• Study Start: 2015-04
• Study First Posted: 2015-04-01
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-05
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 502

Inclusion Criteria

1. Following verbal and written information about the trial, subject must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures
2. Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp

Exclusion Criteria

1. Location of the selected treatment area:

• on the periorbital skin
• on the perioral skin/around the nostrils
• within 5 cm of an incompletely healed wound
• within 10 cm of a suspected BCC or SCC or other neoplasia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group B	Diclofenac sodium gel 3%	Diclofenac sodium gel 3%, (0.5 grams), twice daily for 90 days.
Treatment Group A	Ingenol Mebutate Gel, 0.015%	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.

Primary Outcome Measures

Name	Time	Method
Complete clearance of all AKs	11 Months	Complete clearance of all AKs in the treatment field at Week 8 for ingenol mebutate gel 0.015% and Week 17 for diclofenac sodium gel 3%

Secondary Outcome Measures

Name	Time	Method
Complete clearance of all AKs at Week 17	11 Months	As secondary response criteria, complete clearance at Week 17 for diclofenac sodium gel 3% will be compared with complete clearance in the ingenol mebutate 0.015% group.

Trial Locations

Locations (1)

Gemain, Weber & Craninic; 🇩🇪 Schweinfurt, Germany