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Recruitment Status : Withdrawn (Ingenol mebutato discontinued in Brazil.)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
|Condition or disease||Intervention/treatment||Phase|
|Actinic Cheilitis||Drug: Ingenol mebutate gel||Phase 1 Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|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)|
|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|
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
- Actinic cheilitis response to treatment [ Time Frame: Twelve months ]A 45% partial response to ingenol mebutate
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
|Principal Investigator:||Daniel Cohen Goldemberg, PhD||Researcher|