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:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01998984
First received: November 21, 2013
Last updated: July 8, 2014
Last verified: July 2014
  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
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Partial clearance of AKs [ Time Frame: From baseline to week 8 ] [ Designated as safety issue: No ]

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
-
Drug: ingenol mebutate
Experimental: 1 day placebo and 3 days drug
-
Drug: ingenol mebutate
Placebo Comparator: 4 days placebo
Experimental: 4 days drug
-
Drug: ingenol mebutate

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01998984     History of Changes
Other Study ID Numbers: LP0105-1020
Study First Received: November 21, 2013
Last Updated: July 8, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

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

ClinicalTrials.gov processed this record on July 20, 2014