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A Comparison of Ingenol Mebutate and Cryotherapy for Treatment of Actinic Keratoses.

Phase 0
18 Years
89 Years
Open (Enrolling)
Actinic Keratosis

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Trial Information

A Comparison of Ingenol Mebutate and Cryotherapy for Treatment of Actinic Keratoses.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Change from baseline in visual assessment scores at 3 months

Outcome Description:

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.

Outcome Time Frame:

Baseline and 3 months

Safety Issue:


Principal Investigator

Murad Alam, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University


United States: Institutional Review Board

Study ID:




Start Date:

October 2012

Completion Date:

May 2014

Related Keywords:

  • Actinic Keratosis
  • Keratosis
  • Keratosis, Actinic



Northwestern University Feinberg School of Medicine, Department of Dermatology Chicago, Illinois  60611