Evaluation of Ingenol Mebutate for Actinic Cheilitis Treatment

Brief Title

Evaluation of Ingenol Mebutate for Actinic Cheilitis Treatment

Official Title

Phase 1/2 Clinical Trial for the Evaluation of Ingenol Mebutate for Actinic Cheilitis

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.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Actinic cheilitis response to treatment


Condition

Actinic Cheilitis

Intervention

Ingenol mebutate gel

Study Arms / Comparison Groups

 ingenol mebutate gel
Description:  Phase 1/2, always 3 consecutive days, with 24 hours interval, dosage from 5 mg/cm2 to 18 mg/cm2 in a 3+3 design.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

0

Start Date

February 2020

Completion Date

April 2022

Primary Completion Date

September 2021

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Daniel Cohen Goldemberg, PhD, , 



Administrative Informations


NCT ID

NCT03452566

Organization ID

82279418.6.0000.5274


Responsible Party

Sponsor

Study Sponsor

Instituto Nacional de Cancer, Brazil


Study Sponsor

Daniel Cohen Goldemberg, PhD, Principal Investigator, Researcher


Verification Date

June 2019