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Recruitment Status : Withdrawn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

November 5, 2012
November 28, 2012
June 28, 2016
October 2012
May 2016   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01735942 on Archive Site
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Ingenol Mebutate Compared to Cryotherapy for the Treatment of Skin Lesions
A Comparison of Ingenol Mebutate and Cryotherapy for Treatment of Actinic Keratoses.
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.
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Early Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Actinic Keratosis
  • Drug: Ingenol mebutate
  • Procedure: cryotherapy
  • Experimental: Ingenol Mebutate
    Ingenol Mebutate applied to one side of face with skin lesions
    Intervention: Drug: Ingenol mebutate
  • Active Comparator: Cryotherapy
    Cryotherapy applied to other side of face with skin lesions
    Intervention: Procedure: cryotherapy
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2016
May 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 89 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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United States
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Murad Alam, Northwestern University
Northwestern University
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Principal Investigator: Murad Alam, MD Northwestern University
Northwestern University
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP