Efficacy of Aloe Vera Compared to Corticosteroid in Topical Treatment of Oral Lichen Planus and on Salivary Levels of Tumor Necrosis Factor Alpha

NCT07792512 | Completed Phase 4 DMC

• 1 other identifier: Faculty Of Dentistry
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 5

Brief Summary

Aloe Vera Herbal treatment has been widely used as an anti-inflammatory and antioxidant the objective of this study was to evaluate the clinical efficacy of Aloevera gel compared to corticosteroid gel o for symptomatic oral lichen planus, and to investigate the effect of Aloe Vera or corticosteroids on the expression of Tumor necrosis factor alpha in oral lichen planus as an early marker of inflammation.

Conditions

Oral Lichen Planus; Tumor Necrosis Factor-alpha

Keywords

OLP; Oral Lichen; Oral LP; TNF alpha

Outcome Measures

Primary Outcomes (1)

• Primary Objective

  To compare the clinical efficacy of Aloe Vera gel 70% versus triamcinolone acetonide 0.1% gel in the treatment of symptomatic oral lichen planus (OLP) in terms of lesion size and patient pain The assessment will be carried out at 0, 2, 4 and 8 weeks after starting of the treatment protocol then at 12 weeks after the end of the observational period using the following parameters: 1. Clinical scoring (CS) (Thongprasom et al., 2003) 0: Mild represented no lesion/normal mucosa. 1: White striae/no erythematous area. 2: White striae with atrophic area less than 1 cm2 3: White striae with atrophic area more than 1 cm2 4: White striae with erosive area more than 1cm2 2. Visual Analog Scale (VAS) The VAS consisted of a 10-cm horizontal line marked 0-10 (0 no pain; 10 most severe pain experienced). 3. Imaging and measuring of the oral marker lesion the surface area of the lesion will be outlined and measured using specific image software.

  12 weeks

Secondary Outcomes (1)

• Secondary Objective

  12 weeks

Study Arms (2)

Group 1 Test Group

EXPERIMENTAL

Aloevera Gel

Drug: aloevera gel

Group 2 Control group

ACTIVE COMPARATOR

Topical Corticosteriod

Drug: Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%)

Interventions

aloevera gel DRUG

Mature fresh leaves of Aloe Vera will be washed with fresh, water, their thick epidermis was removed and the solid mucilaginous gel will be collected in a sterile container. The Aloe Vera (AV) gel will consist of 70% AV mucilage, sorbitol, potassium sorbate, sodium metabisulphite and hydroxyethyl-cellulose Dosage : Four times daily for two months

Group 1 Test Group

Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%) DRUG

Each 0.1 mg triamcinolone acetonide in a dental gel containing gelatin, pectin, cream flavor, vanilla flavor and carboxymethylcellulose sodium in Plasticized Hydrocarbon Gel, a polyethylene and mineral oil gel base.

Group 2 Control group

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Both genders, aged ranged from 25 to 60 years.
• Clinically proven painful symptomatic forms of OLP confirmed by the presence of red or erythematous changes, or shallow ulcerations with fine lacy lines at the periphery of the lesion accentuated by stretching and not eliminated by rubbing (Wickham's striae)
• Histopathological proven symptomatic OLP

You may not qualify if:

• History of drug induced lichenoid lesion.
• Presence of systemic conditions as; serious active or recurrent infections, malignancy, diabetes mellitus, hypertension, or significant heart, liver, or renal diseases. Assessed using medical questionnaire guided by Cornell Medical Index.
• Smoking
• Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation as mentioned in history
• Pregnancy or breast-feeding.
• History of previous treatments potentially effective on OLP such as antimalarial agents, retinoid, corticosteroids, or immunosuppressive drugs from less than 2 weeks for topical medications, and 4 weeks for systemic medications prior to starting the study.
• Loss of pliability or flexibility in the tissues involved by the lesions of OLP.
• Histological signs of epithelial dysplasia or lichenoid lesions within the biopsied sites.
• Patients with extensive skin lesions and indicated for systemic corticosteroids.
• Vulnerable groups (Handicapped, orphans or prisoners)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (5)

Faculty Of Dentistry, Ainshams University.

Al ‘Abbāsīyah, Cairo Governorate, 01234, Egypt

Location

Faculty Of Dentistry, Ainshams University.

Al ‘Abbāsīyah, Cairo Governorate, Egypt

Location

Ainshams University

Cairo, Cairo Governorate, 01234, Egypt

Location

Faculty of dentistry Ainshams University

Cairo, Egypt

Location

Faculty Of Dentistry, Ainshams University.

Cairo, Egypt

Location

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Researcher , Faculty of dentistry, AinShams University

Model Details: The study is designed as a Randomized- parallel 2 arm - assessor blinded single center- controlled comparative clinical trial with biochemical analysis

Study Record Dates

• First Submitted: August 22, 2026
• First Posted: August 28, 2026
• Study Start: January 20, 2022
• Primary Completion: February 5, 2025
• Study Completion: August 5, 2025
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (5)