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 @ 12:19 PM
Ignite Modification Date:
2025-12-24 @ 12:19 PM
NCT ID:
NCT00991861
Eligibility Criteria:
Inclusion Criteria:
* At least 4-10 clinically assessed actinic keratosis grade I to II (according to Olsen et al, 1991) in the face/forehead and/or on the bald scalp
* The diameter of each AK target lesion is not less than 0.5 cm and not greater than 1.5 cm
* The target lesions must be located in overall 2 treatment areas with a size of 25 cm2 per treatment area
Exclusion Criteria:
* Have evidence of clinically significant or unstable medical conditions such as:
* metastatic tumor or tumor with high probability of metastatic spread
* heart failure (NYHA class III or higher)
* immunosuppressive disorder (e.g. HIV)
* hematologic, hepatic, renal, neurologic or endocrine disorder.
* collagen-vascular disorder (e.g. cerebrovascular disorder or other bleedings).
* gastrointestinal disorder (e.g. active ulcera or history of recurrent peptic ulcera or hemorrhage)
* Suffer from paresthesia in the treatment areas
* Show Cornu cutaneum of the skin and/or hypertrophic AK lesions in the treatment areas
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00991861
Study Brief:
Protocol Section:
NCT00991861