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.
- Conditions
- Health Condition 1: D899- Disorder involving the immune mechanism, unspecifiedHealth Condition 2: null- Oral Lichen Planus
- Registration Number
- CTRI/2017/11/010321
- Lead Sponsor
- Dr Aniket Uday Vaidya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1. Patients with clinically diagnosed and histologically confirmed Oral Lichen Planus lesions will be included.
2. Age group above 18 years.
3. Patient willing to participate in the study and sign the informed consent.
4. 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.
1. Patients who were clinically diagnosed as OLP but thereafter not confirmed histologically or histologically diagnosed as lichenoid reaction.
2. History of allergy to 0.05% Clobetasol Propionate Ointment or 97 % pure Aloe Vera gel and 94.7% pure Aloe Vera juice.
3. 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.
4. 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 <br/ ><br>2. Difference in the VAS score <br/ ><br>3. Number of sites involved <br/ ><br>4. Lesion characteristics; reticular, plaque, papular, erosive, atrophic or ulcerative <br/ ><br>5. Extraoral site involvement, if anyTimepoint: 1. Difference in the size of the lesion <br/ ><br>2. Difference in the VAS score <br/ ><br>3. Number of sites involved <br/ ><br>4. Lesion characteristics; reticular, plaque, papular, erosive, atrophic or ulcerative <br/ ><br>5. Extraoral site involvement, if any
- Secondary Outcome Measures
Name Time Method 1. Histological characteristics before and after treatment <br/ ><br>2. Recurrence rate <br/ ><br>3. Safety of the drugs / adverse reactionsTimepoint: 1. Histological characteristics before and after treatment <br/ ><br>2. Recurrence rate <br/ ><br>3. Safety of the drugs / adverse reactions