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NCT Number: NCT07792512

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

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.

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Key information

Conditions

Oral Lichen Planus Lichen Planus Lichen Planus, Oral Lichenoid Eruptions Mouth Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Stomatognathic Diseases Tumor Necrosis Factor-alpha

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty Of Dentistry, Ainshams University., Al ‘Abbāsīyah, Cairo Governorate, Egypt

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About this study

Twenty four patients with erosive or atrophic OLP were randomly assigned into two equal groups to receive Aloevera gel (70%) three times per day ( Group 1) , topical steroid ( triamcinolone acetonide 0.1%), four times per day ( Group 2 ),all groups are given treatment for 8 weeks and 4 weeks follow up period without treatment. Photographs of the most severe lesion were taken ( marker lesion ) in each patient and analyzed for total ulcerative area (TUA), total atrophic area (TAA). patients were also assessed using clinical scores (CS) and visual analogue scale (VAS). pre treatment and post treatment specimens were collected through salivary sample to test for expressionof tumor necrosis factor alpa.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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

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.

Primary outcomes

  1. Primary Objective

    Time frame: 12 weeks

    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:

    • 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
    • Visual Analog Scale (VAS) The VAS consisted of a 10-cm horizontal line marked 0-10 (0 no pain; 10 most severe pain experienced).
    • Imaging and measuring of the oral marker lesion the surface area of the lesion will be outlined and measured using specific image software.

Secondary outcomes

  1. Secondary Objective

    Time frame: 12 weeks

    To investigate the effect of Aloe Vera on the salivary level of Tumor Necrosis Factor-alpha The mean concentration of TNF-α in whole saliva of in patients with OLP lesions will be measured by ELISA kit. The assay will be performed according to the manufacturer's instruction (Pezelj-Ribaric S et al ,2004).

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Efficacy of Aloe Vera Compared to Corticosteroid in Topical Treatment of Oral Lichen Planus and on Salivary Levels of Tumor Necrosis Factor Alpha (A Randomized Controlled Clinical Trial With Biochemical Analysis)

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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