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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
Sponsor:
Information provided by (Responsible Party):
Postgraduate Institute of Dental Sciences Rohtak

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.


Condition or disease Intervention/treatment Phase
Oral Leukoplakia Dietary Supplement: topical melatonin Other: PLACEBO Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
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
Other: PLACEBO
Topical application of placebo once daily for 6 weeks with a follow up for 3 months




Primary Outcome Measures :
  1. Change in the size of the lesion. [ Time Frame: four and a half months ]
    measurement of the lesion and scored according to RECIST criteria


Secondary Outcome Measures :
  1. Degree of dysplasia [ Time Frame: four and a half months ]
    Grading of dysplasia according to Speight classification (2007).

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

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


Contacts
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Contact: Sanjay Tewari 01262283876 principalpgidsrohtak@gmail.com

Locations
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India
Post graduate institute of dental sciences Recruiting
Rohtak, Haryana, India, 124001
Contact: Sanjay Tewari, MDS    01262283876    principalpgids@yahoo.in   
Sponsors and Collaborators
Postgraduate Institute of Dental Sciences Rohtak
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Responsible Party: Postgraduate Institute of Dental Sciences Rohtak
ClinicalTrials.gov Identifier: NCT04251845    
Other Study ID Numbers: Shubhangi OMR
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukoplakia
Leukoplakia, Oral
Precancerous Conditions
Neoplasms
Pathological Conditions, Anatomical
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants