Treatment Modalities of Oral Lichen Planus

NCT03237533 | Unknown Early Phase 1

• 1 other identifier: 123456789
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Oral lichen planus (OLP) is a chronic inflammatory mucocutaneous autoimmune disease mainly affecting stratum basal of the epithelium. It is very painful and hamper the daily routine of patients e.g. (talking, drinking, eating, maintaining normal relationships). Different topical treatments have been tried for the symptomatic relief of OLP which include topical corticosteroids (TCSs), topical calcineurin inhibitors (TCIs) retinoids, photochemotherapy; amitryptaline; thalidomide; amlexanox and traditional medicines such as curcumin, selenium-ACE combined with itraconazole, glycyrrhiza glabra and aloe vera. But the exact treatment is still unknown. Objective: To compare the efficacy of Dexamethasone, Doxycycline, Nystatin and Promethazine cocktail with Triamcinolone as topical treatment of OLP Subjects and Methods: 40 patients of symptomatic OLP will be randomly divided in to study and control group. Study group will be given a cocktail containing dexamethasone, doxycycline, nystatin and promethazine and will be advised to rinse with 1 and half teaspoon of this cocktail 3 times a day for 2 minutes for the period of 8 weeks. Study group is also advised to apply an orabase containing 0.1% triamcinolone on lesions 3 times a day for the period of 8 weeks. The control group will be advised to apply only triamcinolone orabase 3 times a day for 8 weeks.

Conditions

Oral Lichen Planus

Outcome Measures

Primary Outcomes (1)

• healing of lesions

  healing of oral lichen planus lesions

  6 bmonths

Study Arms (2)

Study Group

ACTIVE COMPARATOR

in this group patients will be treated with Dexamethasone local application

Drug: Dexamethasone

Control Group

ACTIVE COMPARATOR

in this group patients will be treated with dexamethasone, doxycycline and nystattin

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

Dexamethasone will be applied locally on the lesion

Also known as: Doxycycline, Nystatin, Promethazine, Triamcinolone Orabase

Control Group; Study Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1. Histopathologically proven patients of OLP of all age groups complaining of symptoms such as pain, burning sensitivity to hot and spicy food.
• \. Who have signed informed consent.

You may not qualify if:

• \- 1. Patients who have taken any medication for OLP within 4 weeks before the start of study.
• \. Pregnant and lactating women. 3. History of lichenoid reactions to beta blockers, dapsone, oral hypoglycemics, NSAIDS, pencillamine, phenothiazines, sulfonylureas, gold salts or amalgam fillings.

Sponsors & Collaborators

• University of Faisalabad: lead

Study Sites (1)

The university of Faisalabad

Faisalabad, Punjab Province, 38000, Pakistan

RECRUITING

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Dexamethasone; Doxycycline; Nystatin; Promethazine

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Macrolides; Lactones; Propylamines; Amines; Phenothiazines; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Saima Chaudhry, PhD

  Co-coordinator

  STUDY DIRECTOR

Central Study Contacts

Sadaf Rashid, BDS

CONTACT

+923237791689; durr_e_sadaf@hotmail.com

Arsalan Wahid, M.Phil

CONTACT

+923216685228; dr.arsalanmalik@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator

Study Record Dates

• First Submitted: July 29, 2017
• First Posted: August 2, 2017
• Study Start: June 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 31, 2017
• Last Updated: August 2, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)