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OpenTrials
Completed

NCT Number: 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

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

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Key information

Conditions

Actinic Keratosis (AK) Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gemain, Weber & Craninic

Schweinfurt, 97421, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

  • 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

Treatment and study plan

Ingenol mebutate gel, 0.015%

Drug

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

Other names: Picato®

Diclofenac Sodium Gel 3%

Drug

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

Other names: Solaraze®

Primary outcomes

  1. Complete clearance of all AKs

    Time frame: 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 outcomes

  1. Complete clearance of all AKs at Week 17

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 1, 2015
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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