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

Actinic Keratosis (AK) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02406014
• Other study ID #: LP0041-1120
• Status: Completed
• Phase: Phase 4
• First received: March 27, 2015
• Last updated: May 8, 2017
• Start date: April 2015
• Est. completion date: June 2016

Study information

• Verified date: May 2017
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 502
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Actinic Keratosis (AK)
• Keratosis
• Keratosis, Actinic

Intervention

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

Locations

Country	Name	City	State
Germany	Gemain, Weber & Craninic	Schweinfurt

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete clearance of all AKs	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%	11 Months
Secondary	Complete clearance of all AKs at Week 17	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.	11 Months