Trial record 12 of 30 for:    Arnold-Chiari Malformation

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 is currently recruiting participants.
Verified February 2014 by LEO Pharma
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01998984
First received: November 21, 2013
Last updated: February 11, 2014
Last verified: February 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 ]

Estimated Enrollment: 240
Study Start Date: January 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01998984

Contacts
Contact: Mette K Fife, MSc +45 72262445 mette.kielsholm@leo-pharma.com

Locations
United States, New York
Long Island Skin Cancer and Dermatologic Surgery Recruiting
Smithtown, New York, United States
Contact: Daniel M Siegel, MD MS         
Principal Investigator: Daniel M Siegel, MD MS         
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: February 11, 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 April 17, 2014