Ingenol Mebutate Compared to Cryotherapy for the Treatment of Skin Lesions

Actinic Keratosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01735942
• Other study ID #: STU68227
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: October 2012
• Est. completion date: May 2016

Study information

• Verified date: December 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Ingenol mebutate

Procedure:
• cryotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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