Evaluation of Ingenol Mebutate for Actinic Cheilitis Treatment (NCT03452566) | Clinical Trial Compass
WithdrawnPhase 1/2
Evaluation of Ingenol Mebutate for Actinic Cheilitis Treatment
Stopped: Ingenol mebutato discontinued in Brazil.
0Started 2020-02
Plain-language summary
Actinic cheilitis is a major potentially carcinogenic disorder of the lower lip and several reports of clinical cases with excellent results for the treatment of this lesion that can differentiate to squamous cell carcinoma of the lip. However, clinical trials are lacking to define the optimal dosage of the drug for a therapeutic modality and to define its true efficacy in controlled studies of this pre-malignant labial lesion.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.