Ingenol Mebutate Compared to Cryotherapy for the Treatment of Skin Lesions

Study Overview
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Brief Summary
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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.

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

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Drug: Ingenol mebutate
* Procedure: cryotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ingenol Mebutate<br>Ingenol Mebutate applied to one side of face with skin lesions | Drug: Ingenol mebutate<br> <br> |
| Active Comparator: Cryotherapy<br>Cryotherapy applied to other side of face with skin lesions | Procedure: cryotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in visual assessment scores at 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. | Baseline and 3 months |