A Comparison of Ingenol Mebutate and Cryotherapy for Treatment of Actinic Keratoses.
18 Years
89 Years
Both
Actinic Keratosis
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
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
Type of Study:
Interventional
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:
No
Principal Investigator
Murad Alam, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Northwestern University
Authority:
United States: Institutional Review Board
Study ID:
STU68227
NCT ID:
NCT01735942
Start Date:
October 2012
Completion Date:
May 2014
Related Keywords:
- Actinic Keratosis
- Keratosis
- Keratosis, Actinic
Name | Location |
|---|---|
| Northwestern University Feinberg School of Medicine, Department of Dermatology | Chicago, Illinois 60611 |
