Actinic Cheilitis Clinical Trial
Official title:
Phase 1/2 Clinical Trial for the Evaluation of Ingenol Mebutate for Actinic Cheilitis
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT03224715 -
Actinic Cheilitis Pre-Treated With DNA Repair Enzyme Cream
|
N/A | |
| Not yet recruiting |
NCT03990636 -
Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - Phase 2 Clinical Trial
|
Phase 2 | |
| Terminated |
NCT04219358 -
Topical Application of Imiquimod Gel at Different Concentrations in Actinic Cheilitis
|
Phase 1 | |
| Completed |
NCT00849992 -
Treatment Study for Actinic Cheilitis Comparing Imiquimod 5% and Photodynamic Therapy
|
Phase 4 | |
| Recruiting |
NCT06321003 -
SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography
|
||
| Recruiting |
NCT04744103 -
Trichloroacetic Acid as a Topical Treatment for Actinic Cheilitis
|
Phase 4 | |
| Completed |
NCT00868088 -
Photodynamic Therapy to Treat Actinic Damage in Patients With Squamous Cell Carcinoma (SCC) of the Lip
|
Phase 4 | |
| Completed |
NCT02198469 -
Study of Methyl Aminolaevulinate Photodynamic Therapy With and Without Er:YAG Laser in Actinic Cheilitis
|
Phase 1 | |
| Completed |
NCT02409732 -
Photodynamic Therapy (PDT) With Levulan and Blue Light for the Treatment of Actinic Cheilitis
|
Phase 4 |