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Evaluation of Ingenol Mebutate for Actinic Cheilitis Treatment (EIMAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03452566
Recruitment Status : Withdrawn (Ingenol mebutato discontinued in Brazil.)
First Posted : March 2, 2018
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Instituto Nacional de Cancer, Brazil

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.

Condition or disease Intervention/treatment Phase
Actinic Cheilitis Drug: Ingenol mebutate gel Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Clinical Trial for the Evaluation of Ingenol Mebutate for Actinic Cheilitis
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ingenol mebutate gel
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.
Drug: Ingenol mebutate gel
3+3 phase 1 design as described above. After the maximum tolerated dose is defined, the phase 2 segment of the study will take place. Simon's Phase 2 study design tool was used, reinforced by Jung's admissible study designs for phase 2 clinical trials. Considering the margin of error of 0.05 and study power of 80%, and estimating the probability of placebo partial response of 15% and partial response to ingenol mebutate in 45%, the optimized number of patients to be recruited is 19. Six patients will be seen in the first stage of this segment of the study, and if only one patient or none has a partial response, the study will be promptly discontinued. Otherwise, the second and final stage of segment of the study will include an additional thirteen patients who will be treated.
Other Name: Picato




Primary Outcome Measures :
  1. Actinic cheilitis response to treatment [ Time Frame: Twelve months ]
    A 45% partial response to ingenol mebutate



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452566


Sponsors and Collaborators
Instituto Nacional de Cancer, Brazil
Investigators
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Principal Investigator: Daniel Cohen Goldemberg, PhD Researcher
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Responsible Party: Instituto Nacional de Cancer, Brazil
ClinicalTrials.gov Identifier: NCT03452566    
Other Study ID Numbers: 82279418.6.0000.5274
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Instituto Nacional de Cancer, Brazil:
actinic cheilitis
ingenol mebutate
treatment
phase 1/2 clinical trial
Additional relevant MeSH terms:
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Cheilitis
Lip Diseases
Mouth Diseases
Stomatognathic Diseases