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.

A Randomised Parallel Clinical Trial To Compare The Efficacy Of Topical Application Of 97% Aloe Vera Gel Along With 94.7% Aloe Vera Juice Versus 0.05% Clobetasol Propionate Topical Application In The Treatment Of Oral Lichen Planus

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/11/010321

Enrollment

Registered

2017-11-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D899- Disorder involving the immune mechanism, unspecified Health Condition 2: null- Oral Lichen Planus

Interventions

Intervention1: Aloe vera gel, Aloe vera juice: 97% pure Aloe vera gel local intraoral topical application on the affected area BD for 2 months 94.7% pure Aloe vera juice 10 ml BD on empty stomach for

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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 anyTimepoint: 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	—

Measure

Time frame

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 anyTimepoint: 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

Measure	Time frame
1. Histological characteristics before and after treatment 2. Recurrence rate 3. Safety of the drugs / adverse reactionsTimepoint: 1. Histological characteristics before and after treatment 2. Recurrence rate 3. Safety of the drugs / adverse reactions	—

Countries

India

Contacts

Public ContactDr Aniket Uday Vaidya

Goa University

khoratemanisha@rediffmail.com9823213773

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026