Ingenol Mebutate Compared to Cryotherapy for the Treatment of Skin Lesions
This study is currently recruiting participants.
Verified November 2012 by Northwestern University
Sponsor:
Northwestern University
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT01735942
First received: November 5, 2012
Last updated: November 21, 2012
Last verified: November 2012
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Purpose
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 |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (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 Northwestern University:
Primary Outcome Measures:
- Change from baseline in visual assessment scores at 3 months [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (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 |
Eligibility| Ages Eligible for Study: | 18 Years to 89 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735942
Contacts
| Contact: Emily Poon, PhD | 312-695-4761 | research.nuderm@northwestern.edu |
Locations
| United States, Illinois | |
| Northwestern University Feinberg School of Medicine, Department of Dermatology | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Emily Poon, PhD 312-695-4761 research.nuderm@northwestern.edu | |
| Principal Investigator: Murad Alam, MD | |
Sponsors and Collaborators
Northwestern University
Investigators
| Principal Investigator: | Murad Alam, MD | Northwestern University |
More Information
No publications provided
| Responsible Party: | Murad Alam, Professor in Dermatology, Otolaryngology- Head and Neck Surgery and Surgery-Organ Transplantation, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT01735942 History of Changes |
| Other Study ID Numbers: | STU68227 |
| Study First Received: | November 5, 2012 |
| Last Updated: | November 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Keratosis Keratosis, Actinic Skin Diseases Precancerous Conditions Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013