- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03452566
Evaluation of Ingenol Mebutate for Actinic Cheilitis Treatment (EIMAC)
Phase 1/2 Clinical Trial for the Evaluation of Ingenol Mebutate for Actinic Cheilitis
Study Overview
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 Type
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Actinic cheilitis response to treatment
Time Frame: Twelve months
|
A 45% partial response to ingenol mebutate
|
Twelve months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Daniel Cohen Goldemberg, PhD, Researcher
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 82279418.6.0000.5274
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Actinic Cheilitis
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Loyola UniversityWithdrawn
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Hospital de Clinicas de Porto AlegreFederal University of Rio Grande do SulTerminatedActinic CheilitisBrazil
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Norwegian University of Science and TechnologySt. Olavs HospitalCompletedActinic CheilitisNorway
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Nova Scotia Health AuthorityRecruiting
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Dartmouth-Hitchcock Medical CenterDUSA Pharmaceuticals, Inc.CompletedActinic CheilitisUnited States
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Dong-A UniversityCompletedActinic CheilitisKorea, Republic of
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Instituto Nacional de Cancer, BrazilUnknownLeukoplakia | Erythroplakia | Actinic Cheilitis
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Tufts Medical CenterDUSA Pharmaceuticals, Inc.CompletedActinic Cheilitis | Squamous Cell Carcinoma In-situ (SCC-is) | Squamous Cell Carcinoma (SCC) | Photodynamic Therapy (PDT) | Mohs SurgeryUnited States
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University of PalermoRecruitingOral Disease | Oral Cancer | Actinic Keratoses | Oral Leukoplakia | Oral Squamous Cell Carcinoma | Oral Lichen Planus | Graft-versus-host-disease | Proliferative Verrucous Leukoplakia | Actinic Cheilitis | Oral Potentially Malignant Disorder | Oral Erythroplakia | Oral Lichenoid LesionItaly
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Cosmetique Active InternationalNot yet recruiting
Clinical Trials on Ingenol mebutate gel
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Korea UniversitySamsung Medical Center; Asan Medical Center; Chonnam National University Hospital and other collaboratorsCompletedActinic KeratosisKorea, Republic of
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PeplinCompleted
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PeplinCompleted
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Padagis LLCCompleted
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PeplinCompletedActinic KeratosisUnited States
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PeplinCompleted
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LEO PharmaCompletedActinic KeratosisUnited States
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LEO PharmaCompletedActinic KeratosisAustralia, Germany
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PeplinCompletedActinic KeratosisUnited States