Clinical trial · Interventional
Evaluation of Effect of Topical Melatonin in Treatment of Oral Leukoplakia
Evaluation of Effect of Topical Melatonin in Treatment of Oral Leukoplakia: A Randomized Placebo Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Leukoplakia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PLACEBO | Other | — | UNRESOLVED |
| topical melatonin | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Trial group
- description
- Intervention : Topical Melatonin(3%) at dosage of 15 mg once daily
- interventionNames
- Dietary Supplement: topical melatonin
- type
- PLACEBO_COMPARATOR
- label
- Control Group
- description
- Intervention : Placebo once daily
- interventionNames
- Other: PLACEBO
Primary outcomes (1)
- measure
- Change in the size of the lesion.
- timeFrame
- four and a half months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Clinically and histologically proven cases of leukoplakia associated with tobacco. With age 18 years and above. Willing and able to participate in the study and signed informed consent. Exclusion Criteria: Patients suspicious of malignant transformation of the lesion with frank ulceration or growth. Patients consuming or have consumed drugs for treatment of leukoplakia. Patients who have red or white lesions persisting after radiotherapy treatment Patients with acquired and congenital immunodeficiency disorders like AIDS, chemotherapy, addiction to injectable opioids and any other significant medical or systemic or autoimmune conditions. Pregnancy or lactation phase. Known allergy to melatonin.
References
Publications (0)
Data not yet available