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 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT03452566
Eligibility Criteria:
Inclusion Criteria:
* Patients with diagnosis of actinic cheilitis .
* Histopathological report compatible with the clinical diagnosis.
* Sign the informed consent to be a part of the study.
* Comply with the attendance at the clinical settings during the days the patient will be medicated (D1, D2 and D3), D5, D8, two months, six months and one year after treatment.
Exclusion Criteria:
* Patients younger than 18 years of age.
* Patients without confirmed diagnosis of actinic cheilitis.
* Patients previously treated with ingenol mebutate for actinic cheilitis, including those in the present study, previously excluded at some point during phases 1 or 2.
* Presence of recurrent lesions, prior or during treatment.
* Immunosuppression.
* Use of topical corticosteroids.
* Presence of markedly hyperkeratotic or ulcerated lesions in the clinical evaluation
* Patients presenting with atypical histology (moderate to severe epithelial dysplasia) at the lips.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03452566
Study Brief:
Protocol Section:
NCT03452566