Evaluation of Effect of Topical Melatonin in Treatment of Oral Leukoplakia
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04251845|
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Oral leukoplakia is the most commonly occurring oral premalignant disorder. It has an overall prevalence rate of 1-4% with highest prevalence rate of 10.54% in Asian countries. The management of leukoplakia includes conventional as well as surgical modalities. The conventional approaches include Beta Carotene, Lycopene, ascorbic acid, alpha tocopherol, retinoids. But, no significant results are documented on regression rate and prevention of recurrence of the lesions.
Melatonin chemically N-acetyl-5-methoxytryptamine is a hormone produced in the pineal gland. It is synthesized from the amino acid, tryptophan. The basic physiological function of melatonin is to control day night cycle and hence is commonly used in insomnia, jet lag and some other psychological disorders.
Melatonin has a potent antioxidant effect and other actions such as modulation of cell cycle and induction of apoptosis, inhibition of telomerase activity, inhibition of metastasis, prevention of circadian disruption, anti-angiogenesis and stimulation of cell differentiation
To date, no treatment modality has demonstrated its clear superiority for leukoplakia. There are many pathways by which melatonin can be used beneficially for management oral leukoplakia.
|Condition or disease||Intervention/treatment||Phase|
|Oral Leukoplakia||Dietary Supplement: topical melatonin Other: PLACEBO||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Evaluation of Effect of Topical Melatonin in Treatment of Oral Leukoplakia: A Randomized Placebo Controlled Study|
|Estimated Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||August 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
Active Comparator: Trial group
Intervention : Topical Melatonin(3%) at dosage of 15 mg once daily
Dietary Supplement: topical melatonin
Topical melatonin at 3% concentration with dosage of 15 mg once daily will be applied on the lesion for 6 weeks followed by a follow up of 3 months
Placebo Comparator: Control Group
Intervention : Placebo once daily
Topical application of placebo once daily for 6 weeks with a follow up for 3 months
- Change in the size of the lesion. [ Time Frame: four and a half months ]measurement of the lesion and scored according to RECIST criteria
- Degree of dysplasia [ Time Frame: four and a half months ]Grading of dysplasia according to Speight classification (2007).
- Expression of immunopositivity of ki67 cells in the lesion. [ Time Frame: four and a half months ]Percentage of a total number of Ki-67 positive cells to a total number of cells will be primarily deducted.
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): NCT04251845
|Contact: Sanjay Tewariemail@example.com|
|Post graduate institute of dental sciences||Recruiting|
|Rohtak, Haryana, India, 124001|
|Contact: Sanjay Tewari, MDS 01262283876 firstname.lastname@example.org|