oral leukoplakia
Conditions
Interventions
Experimental group:For the first 2 weeks, participants take 10 mg of tretinoin tablets for oral use once daily
for the 3rd-24th week, participants take 10 mg of tretinoin tablets twice a day.
Delayed treatment group:For the first 2 weeks, participants take 10 mg of placebo tablets for oral use once daily
for the 3rd to 12th weeks, participants take 10 mg of placebo tablets twice a day
for the 13th to 24th weeks, participants take 10 mg of tretinoin tablets orally twice a day.
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University, School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria: ? age 18-75 years; ? area of oral leukoplakia =2 cm2, and confirmed as oral leukoplaia by histopathological examination; ? no significant abnormalities in blood routine, glucose, liver function, renal function, electrolytes, urine routine, etc. (alanine aminotransferase = 1.5 times the upper limit of normal value, aspartate aminotransferase = 1.5 times the upper limit of normal value, total bilirubin = 1.5 times the upper limit of normal value, creatinine = 1.5 times the upper limit of normal value, urea nitrogen = 1.5 times the upper limit of normal value); ? women with reproductive potential must have a negative urine pregnancy test within two weeks before starting the study. Postmenopausal women (defined as having no menstruation for at least one year) and surgically sterilized women do not need to undergo pregnancy testing; ? able to comply with the schedule of study visits, understand and comply with all trial protocol requirements; ? able and willing to sign the informed consent form; ? must be able to swallow and retain oral medications; ? independently participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Participants who meet any of the following criteria will not be included in this study: ? with severe systemic diseases that cannot be controlled by medication; ? allergic to retinoids; ? received systemic immunotherapy within three months or received local treatment within one week before the start of the study; ? have other severe oral mucosal diseases; ? pregnant or breastfeeding women; ? with multiple factors that affect oral medication (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction); ? with a history of abuse of psychotropic drugs and unable to quit or with mental disorders; ? with other concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy rate at week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy rate at Week 4, 8, 16, 20, 24;Complete remission rate at Week 4, 8, 12, 16, 20, 24;Partial remission rate at Week 4, 8, 12, 16, 20, 24;Degree of subjective discomfort at Week 4, 8, 12, 16, 20, 24;VELscope menifestation at Week 4, 8, 12, 16, 20, 24; | — |
Countries
China
Contacts
Public ContactKai Sun
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University, School of Medicine
Outcome results
None listed