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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

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ClinicalTrials.gov Identifier: NCT02406014
Recruitment Status : Completed
First Posted : April 1, 2015
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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

Condition or disease Intervention/treatment Phase
Actinic Keratosis (AK) Drug: Ingenol Mebutate Gel, 0.015% Drug: Diclofenac sodium gel 3% Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 502 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.
 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.
Other Name: Picato®
Active Comparator: Treatment Group B
Diclofenac sodium gel 3%, (0.5 grams), twice daily for 90 days.
 Drug: Diclofenac sodium gel 3%
Diclofenac sodium gel 3% Solaraze® applied on the selected treatment area, twice daily for 90 days.
Other Name: Solaraze®


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406014


Locations
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Germany
Gemain, Weber & Craninic
Schweinfurt, Germany, 97421
Sponsors and Collaborators
LEO Pharma
Investigators
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Principal Investigator: Eggert Stockfleth, Prof.Dr.med. St. Josef-Hospital im Katholischen Klinikum Bochum
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02406014    
Other Study ID Numbers: LP0041-1120
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action