Efficacy and safety of tetrahydrocurcuminoid in the treatment of oral leukoplakia: A pilot study

Objective: The objective of this study is to evaluate the efficacy and safety of tetrahydrocurcuminoid (THC) in the treatment of oral leukoplakia. Methods: Patients with oral mucosal lesions with clinical features of leukoplakia were selected, and an incisional biopsy of the lesion was performed to confirm the diagnosis. Demographic data, habit history, and complete medical history were documented. Subjects were given 2% THC gel (Sami Labs, Bengaluru) with advice to apply the gel to the affected areas, 5 times daily for 12 weeks. The lesion was examined, and its characteristics were documented in a standard manner at baseline, 3, 6, 9, and 12 weeks. Results: Of the eight patients, 6 were males with age range from 40 to 70 years (mean age of 56 years). All the patients reported a reduction of burning sensation within 3 weeks of starting treatment and were completely asymptomatic by the end of the study. There was a decrease in the size of the lesion during the follow-up period. Reduction in thickness of the lesion was found in six of eight patients. Histological improvement a stage better was seen in three patients after completion of treatment. However, there was no histological improvement in four patients, and one patient progressed to mild dysplasia from hyperkeratosis without dysplasia. Conclusion: THD when topically applied in gel form is remarkably effective in alleviating clinical symptoms. The remarkable histological improvement was seen in 3 of 8 patients.