A clinical trial to study and compare the effects of two medications; corticosteroids (Clobetasol Propionate) and Aloe Vera in the treatment of Oral Lichen Planus.

Phase 2

Completed

• Conditions: Disorder involving the immune mechanism, unspecified, Oral Lichen Planus,

• Registration Number: CTRI/2017/11/010321
• Lead Sponsor: Dr Aniket Uday Vaidya

Brief Summary

This study is a randomized, parallel group, clinical trial comparing the efficacy topical application of 97% Aloe vera gel and 94.7% Aloe vera juice versus 0.05% Clobetasol Propionate Ointment topical application for 2 months in 60 patients with Oral lichen Planus. This study will include the patients attending the Oral Medicine and Radiology Dept. Out Patient Dept., Goa Dental College and Hospital, Bambolim, Goa. All the patients will be followed up on monthly basis for a period of 6 months. The primary outcome measures will be difference in the size of the lesion, difference in the VAS score, number of sites involved, lesion characteristics; reticular, plaque, papular, erosive, atrophic or ulcerative, extra-oral site involvement, if any. The secondary outcomes will be changes histological characteristics before and after treatment, recurrence rate and safety of the drugs / adverse reactions.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-09
• Study Completion: 2018-01-31
• Last Update Posted: 2020-08-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with clinically diagnosed and histologically confirmed Oral Lichen Planus lesions will be included.
• Age group above 18 years.
• Patient willing to participate in the study and sign the informed consent.
• Patients given medical clearance by General Medicine Dept., Goa Medical College for being included in the trial in spite of of the medical conditions like hypertension, diabetes mellitus and hyperthyroidism etc 5.
• If patient is under any other systemic medications or topical treatment for oral lichen planus then in such cases the patients will be included in this study three months after cessation of the current systemic steroidal treatment or one month after cessation of non-steroidal systemic treatment or steroidal / non-steroidal topical treatment if the lesions have still persisted.

Exclusion Criteria

• Patients who were clinically diagnosed as OLP but thereafter not confirmed histologically or histologically diagnosed as lichenoid reaction.
• History of allergy to 0.05% Clobetasol Propionate Ointment or 97 % pure Aloe Vera gel and 94.7% pure Aloe Vera juice.
• Medically compromised patients who could not be put on topical steroids or Aloe Vera as advised by the General Medicine Dept., Goa Medical College, Bambolim-Goa.
• Pregnant or Lactating females.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Difference in the size of the lesion	1. Difference in the size of the lesion | 2. Difference in the VAS score | 3. Number of sites involved | 4. Lesion characteristics; reticular, plaque, papular, erosive, atrophic or ulcerative | 5. Extraoral site involvement, if any
2. Difference in the VAS score	1. Difference in the size of the lesion | 2. Difference in the VAS score | 3. Number of sites involved | 4. Lesion characteristics; reticular, plaque, papular, erosive, atrophic or ulcerative | 5. Extraoral site involvement, if any
3. Number of sites involved	1. Difference in the size of the lesion | 2. Difference in the VAS score | 3. Number of sites involved | 4. Lesion characteristics; reticular, plaque, papular, erosive, atrophic or ulcerative | 5. Extraoral site involvement, if any
4. Lesion characteristics; reticular, plaque, papular, erosive, atrophic or ulcerative	1. Difference in the size of the lesion | 2. Difference in the VAS score | 3. Number of sites involved | 4. Lesion characteristics; reticular, plaque, papular, erosive, atrophic or ulcerative | 5. Extraoral site involvement, if any
5. Extraoral site involvement, if any	1. Difference in the size of the lesion | 2. Difference in the VAS score | 3. Number of sites involved | 4. Lesion characteristics; reticular, plaque, papular, erosive, atrophic or ulcerative | 5. Extraoral site involvement, if any

Secondary Outcome Measures

Name	Time	Method
1. Histological characteristics before and after treatment	2. Recurrence rate

Trial Locations

Locations (1)

Goa Dental College and Hospital; 🇮🇳 Goa, GOA, India

Goa Dental College and Hospital

🇮🇳Goa, GOA, India

Dr Aniket Uday Vaidya

Principal investigator

8390541605

draniketvaidya@gmail.com