Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT02120456
Eligibility Criteria:
Inclusion Criteria:
* Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the arm
* Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the extremities or trunk
Exclusion Criteria:
* Location of the treatment area
* within 5 cm of an incompletely healed wound
* within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
* Prior treatment with ingenol mebutate gel on the treatment area
* Lesions in the treatment areas that have:
* atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or
* recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02120456
Study Brief:
Protocol Section:
NCT02120456