Clinical trial NCT03452566: Evaluation of Ingenol Mebutate for Actinic Cheilitis Treatment
Official title: Phase 1/2 Clinical Trial for the Evaluation of Ingenol Mebutate for Actinic Cheilitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Actinic Cheilitis
Keywords: actinic cheilitis
ingenol mebutate
treatment
phase 1/2 clinical trial
Lead sponsor: Instituto Nacional de Cancer, Brazil
Sponsor class: OTHER_GOV
First posted: 2018-03-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: To determine the toxicity profile and the maximum tolerated dose (MTD) of ingenol mebutate for treatment of actinic cheilitis and to determine the therapeutic response with a dose below the maximum tolerated dose (MTD). The MTD will be tested in the phase 2 stage of this study.
Primary purpose: TREATMENT

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 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.

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 vermilion surface especially in white patients (patients with genodermatosis such as xeroderma pigmentosum have extreme sensitivity to UV radiation, characterized by an even higher risk and patients presenting radiodermatites that can evolve to squamous cell carcinoma). Ingenol mebutate is a natural medicine derived from the sap of the pepense euphoria and much used for its medicinal properties.

The objective of this study was to determine the toxicity profile and the maximum tolerated dose (MTD) of ingenol mebutate for treatment of actinic cheilitis in patients of the Oncology Dermatology Session of the National Cancer Institute of Brazil (INCA) through a phase 1 clinical trial of type 3 + 3 and to determine the therapeutic response with a dose below the maximum tolerated dose (MTD) of metamato of ingenuity, for the treatment of aortic cheilitis in patients of the Oncology Dermatology Session of the National Cancer Institute (INCA) through a prospective clinical trial and phase randomized trial (phase 2).

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.

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.

Primary outcomes:
measure: Actinic cheilitis response to treatment
timeFrame: Twelve months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Researcher
name: Daniel Cohen Goldemberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: