A Phase 4 interventional study of aloevera gel and Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%) in Oral Lichen Planus and Tumor Necrosis Factor-alpha, sponsored by Ain Shams University. Completed at 5 sites in Egypt. Open to participants aged 25 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Ain Shams University · Phase 4, Interventional, and Treatment
Among 10 studies in Lichen Planus, Oral by Ain Shams University — 3 open to participants now, 4 under way, none of them phase 3. Lichen Planus, Oral · Ain Shams University.
Among the 10 studies in Lichen Planus, Oral by Ain Shams University, this one is the only one that started in 2022, is one of 7 in phase 4, and was the 9th registered.
142 studies on the registry are indexed under Lichen Planus, Oral; 27 are open to participants now.
Browse Lichen Planus, Oral studies →3 of the 10 studies in Lichen Planus, Oral by Ain Shams University are open now. Recruiting first, the newest first:
Ain Shams University
Ages 30–75
Ain Shams University
Ages 40–75 · Healthy volunteers
Ain Shams University
Ages 40–60
Of the 14 Lichen Planus, Oral studies recruiting now, 10 (71%) set no upper age limit and 2 (14%) stop at 75 or younger; 3 take children under 18; 3 take healthy volunteers.
This study: 25 Years to 60 Years · all sexes · healthy volunteers too.
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10 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 1 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 24 is below the median of 39 across 101 interventional studies indexed under Lichen Planus, Oral.
Median enrollment 29 across the 8 interventional studies, 70 across the 2 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.
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Ain Shams University is the lead sponsor of 1,953 studies on the registry; 430 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
2 of the studies in Lichen Planus, Oral by Ain Shams University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07318922Ain Shams UniversityEvaluation of Artificial Intelligence in Diagnosis and Risk Assessment of Oral Potentially Malignant Disorders | 2026-11-22 |
| NCT07846891Ain Shams UniversityLow Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus | 2027-04-20 |
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Among the 10 studies in Lichen Planus, Oral by Ain Shams University, from their registry updates:
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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.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Aloevera Gel
Drug: aloevera gel
Topical Corticosteriod
Drug: Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%)
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
Drug page: Triamcinolone Acetonide
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 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.
Time frame: 12 weeks
Secondary Objective
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).
Time frame: 12 weeks
Plan to share: No — No plan to make individual participant data ( IPD) available at this time. data maybe shared upon reasonable request to corresponding author subject to institutional approval
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Ran from Jan 2022 to primary completion in Feb 2025, 36 months.
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