Evaluation of Ingenol Mebutate for Actinic Cheilitis Treatment

• Status: Withdrawn
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Cancer, Brazil

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.