We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01998984
First Posted: December 3, 2013
Last Update Posted: August 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
LEO Pharma
  Purpose
This is a randomised, double-blind, parallel groups, vehicle controlled, 8-week phase 2 trial. The objective is to evaluate efficacy of ingenol mebutate gel 0.06 % after once daily treatment for 2, 3 or 4 consecutive days compared to vehicle gel

Condition Intervention Phase
Actinic Keratosis Drug: ingenol mebutate Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Complete clearance of AKs [ Time Frame: Week 8 ]
    To evaluate efficacy of ingenol mebutate gel after once daily treatment for 2, 3 or 4 consecutive days compared to vehicle gel


Secondary Outcome Measures:
  • Reduction in AK count [ Time Frame: From baseline to week 8 ]
  • Partial clearance of AKs [ Time Frame: From baseline to week 8 ]

Enrollment: 223
Study Start Date: January 2014
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2 days placebo and 2 days drug
Placebo and drug
Drug: ingenol mebutate Other: Placebo
Experimental: 1 day placebo and 3 days drug
Placebo and drug
Drug: ingenol mebutate Other: Placebo
Placebo Comparator: 4 days placebo
Placebo
Other: Placebo
Experimental: 4 days drug
Drug
Drug: ingenol mebutate

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

Subjects with 5 to 20 clinically typical, visible and discrete AKs within a contiguous area of approximately 250 cm² sun-damaged skin on either trunk (except chest), or extremities

Exclusion Criteria:

  • Location of the treatment area (trunk (except chest) or extremities)

    • within 5 cm of an incompletely healed wound,
    • within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
  • Prior treatment with ingenol mebutate within the selected treatment area
  • Lesions in the treatment area that have:

    • atypical clinical appearance (e.g., hypertrophic,hyperkeratotic or cutaneous horns) and/or,
    • recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions)
  Contacts and Locations
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): NCT01998984


Locations
United States, New York
Long Island Skin Cancer and Dermatologic Surgery
Smithtown, New York, United States
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Daniel M Siegel, MD, MS Lond Island Skin Cancer and Dermatologic Surgery
  More Information

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01998984     History of Changes
Other Study ID Numbers: LP0105-1020
First Submitted: November 21, 2013
First Posted: December 3, 2013
Last Update Posted: August 23, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms