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Ingenol Mebutate Compared to Cryotherapy for the Treatment of Skin Lesions

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Murad Alam, Northwestern University Identifier:
First received: November 5, 2012
Last updated: June 27, 2016
Last verified: June 2016
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 Early Phase 1

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Murad Alam, Northwestern University:

Primary Outcome Measures:
  • 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.

Enrollment: 0
Study Start Date: October 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (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


Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01735942

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

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
Study First Received: November 5, 2012
Last Updated: June 27, 2016

Additional relevant MeSH terms:
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms processed this record on September 21, 2017