Ingenol Mebutate Compared to Cryotherapy for the Treatment of Skin Lesions

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. Identifier: NCT01735942
Recruitment Status : Withdrawn
First Posted : November 28, 2012
Last Update Posted : June 28, 2016
Information provided by (Responsible Party):
Murad Alam, Northwestern University

Brief Summary:
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 or disease Intervention/treatment Phase
Actinic Keratosis Drug: Ingenol mebutate Procedure: cryotherapy Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Ingenol Mebutate and Cryotherapy for Treatment of Actinic Keratoses.
Study Start Date : October 2012
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change from baseline in visual assessment scores at 3 months [ Time Frame: Baseline and 3 months ]
    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.

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT01735942

Sponsors and Collaborators
Northwestern University
Principal Investigator: Murad Alam, MD Northwestern University

Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology- Head and Neck Surgery and Surgery-Organ Transplantation, Northwestern University Identifier: NCT01735942     History of Changes
Other Study ID Numbers: STU68227
First Posted: November 28, 2012    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016

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