Evaluation of Effect of Topical Melatonin in Treatment of Oral Leukoplakia

NCT04251845 | Unknown

• 1 other identifier: Shubhangi OMR
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Oral Leukoplakia

Outcome Measures

Primary Outcomes (1)

• Change in the size of the lesion.

  measurement of the lesion and scored according to RECIST criteria

  four and a half months

Secondary Outcomes (2)

• Degree of dysplasia

  four and a half months

• Expression of immunopositivity of ki67 cells in the lesion.

  four and a half months

Study Arms (2)

Trial group

ACTIVE COMPARATOR

Intervention : Topical Melatonin(3%) at dosage of 15 mg once daily

Dietary Supplement: topical melatonin

Control Group

PLACEBO COMPARATOR

Intervention : Placebo once daily

Other: PLACEBO

Interventions

topical melatonin DIETARY_SUPPLEMENT

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

Trial group

PLACEBO OTHER

Topical application of placebo once daily for 6 weeks with a follow up for 3 months

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post graduate institute of dental sciences

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Leukoplakia, Oral

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Leukoplakia; Precancerous Conditions; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Sanjay Tewari

CONTACT

01262283876; principalpgidsrohtak@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 5, 2020
• Study Start: February 1, 2020
• Primary Completion: August 30, 2020
• Study Completion: September 30, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-01

Locations

IN (1)