Status:
WITHDRAWN
Evaluation of Ingenol Mebutate for Actinic Cheilitis Treatment
Lead Sponsor:
Instituto Nacional de Cancer, Brazil
Conditions:
Actinic Cheilitis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
Squamous cell carcinoma is the most common malignant neoplasm in the head and neck region, and when present in the lower lip, it is usually associated with prolonged exposure to UV radiation of lip ve...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03452566
Start Date
February 1 2020
End Date
April 1 2022
Last Update
June 19 2019
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