Ingenol Mebutate Compared to Cryotherapy for the Treatment of Skin Lesions

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT01735942
First received: November 5, 2012
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to find out the effectiveness of ingenol mebutate compared to cryotherapy (freezing of the tissue) for the treatment of face and scalp skin lesions.


Condition Intervention Phase
Actinic Keratosis
Drug: Ingenol mebutate
Procedure: cryotherapy
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Ingenol Mebutate and Cryotherapy for Treatment of Actinic Keratoses.

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Change from baseline in visual assessment scores at 3 months [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    The visual assessment evaluates seven clinical signs: erythema, edema, wheal vesiculation, ulceration, hemorrhage, purpura, and crusting. Each sign is assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a better outcome, and a score of 3 is associated with severe expression of the clinical sign and a worse outcome.


Estimated Enrollment: 20
Study Start Date: October 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ingenol Mebutate
Ingenol Mebutate applied to one side of face with skin lesions
Drug: Ingenol mebutate
Active Comparator: Cryotherapy
Cryotherapy applied to other side of face with skin lesions
Procedure: cryotherapy

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female subjects between 18 and 89 years old.
  • Have at least a total of 10 non-hypertrophic actinic keratoses (AKs) on the face and scalp
  • The subjects are in good health
  • The subjects have the willingness and the ability to understand and provide informed consent for the use of their tissue and are able to communicate with the investigator

Exclusion Criteria:

  • Subjects under 18 years of age and over the age of 89
  • Subjects who are pregnant or lactating
  • Subjects with sensitivity to cold
  • Subjects with use of topical medications such as corticosteroids, alpha-hydroxyacids or retinoids 2 weeks before study entry
  • Subjects who received previous treatment of target AKs
  • Subjects whose target treatment area was within 5 cm of an incompletely healed wound or within 10 cm of a suspected basal-cell or squamous-cell carcinoma
  • Subjects with use of medications or other treatments that could interfere with evaluation of the treatment area within 2 months before study entry (e.g., topical medications, artificial tanners, immunosuppressive medications, immunomodulating agents, cytotoxic drugs, ultraviolet B phototherapy, other therapies for actinic keratoses, or oral retinoids)
  • Subjects who are unable to understand the protocol or to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735942

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University
  More Information

No publications provided

Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology- Head and Neck Surgery and Surgery-Organ Transplantation, Northwestern University
ClinicalTrials.gov Identifier: NCT01735942     History of Changes
Other Study ID Numbers: STU68227
Study First Received: November 5, 2012
Last Updated: July 16, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 21, 2014