Oral Lichen PlanusPhase 4NCT07792512

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

A Phase 4 study testing aloevera gel and Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%) in people with Oral Lichen Planus and Tumor Necrosis Factor-alpha, run by Ain Shams University at 5 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 25 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Oral Lichen Planus, Tumor Necrosis Factor-alpha
What is being tested?: aloevera gel and Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 5 sitesEgypt
Study dates: 20 Jan 2022to 5 Aug 2025
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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.

Show all 10Show fewer

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)

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Egypt5 sites

Faculty Of Dentistry, Ainshams University.
Al ‘Abbāsīyah, Cairo Governorate, 01234
Faculty Of Dentistry, Ainshams University.
Al ‘Abbāsīyah, Cairo Governorate
Ainshams University
Cairo, Cairo Governorate, 01234
Faculty of dentistry Ainshams University
Cairo
Faculty Of Dentistry, Ainshams University.
Cairo

Other trials in Egypt

About this study

Official 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)

Read the detailed description

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.

Conditions: Oral Lichen Planus, Tumor Necrosis Factor-alpha
Being tested: aloevera gel, Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%)
Keywords: OLP, Oral Lichen, Oral LP, TNF alpha
Medical subject headings: Lichen Planus, Oral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

aloevera gelDrug
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.

Study groups in NCT07792512
Study group	Role	What they receive
Group 1 Test Group	Experimental	Aloevera Gel Receives: Drug: aloevera gel
Group 2 Control group	Active comparator	Topical Corticosteriod Receives: Drug: Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 weeks

Secondary outcomes (1)

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).
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jan 20225 Aug 2025

First posted28 Aug 2026
Study start20 Jan 2022
Primary completion5 Feb 2025
Study completion5 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
More trials run by Ain Shams UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: The study is designed as a Randomized- parallel 2 arm - assessor blinded single center- controlled comparative clinical trial with biochemical analysis
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07792512
Sponsor's protocol ID: Faculty Of Dentistry
Status last verified: Aug 2026
First submitted: 22 Aug 2026
Last updated: 28 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
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Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
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Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
Degree of Adherence of Symptomatic OLP Patients to Their Medications
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Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus
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Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
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All Oral Lichen Planus trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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)
ClinicalTrials.gov ID: NCT07792512
Acronym / sponsor ID: Faculty Of Dentistry
Conditions: Oral Lichen Planus, Tumor Necrosis Factor-alpha
Keywords: OLP, Oral Lichen, Oral LP, TNF alpha
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Ain Shams UniversityUniversity, hospital or other
Study start: 20 Jan 2022 (actual)
Primary completion: 5 Feb 2025 (actual)
Study completion: 5 Aug 2025 (actual)
First posted: 28 Aug 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2
Model description: The study is designed as a Randomized- parallel 2 arm - assessor blinded single center- controlled comparative clinical trial with biochemical analysis

Arm	Type	Receives
Group 1 Test Group	Experimental	Drug: aloevera gelAloevera Gel
Group 2 Control group	Active comparator	Drug: Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%)Topical Corticosteriod

Who may qualify

Ages: 25 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
aloevera gelMature 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	Group 1 Test Group
Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%)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.	Drug	Group 2 Control group

Primary outcome

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: 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.

1 secondary outcome

Secondary Objective
Time frame: 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
Individual participant dataSharing planned: 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

Related trials for Oral Lichen Planus

RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Not yet recruiting
Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
Oral Lichen Planus
Not yet recruiting
Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
Degree of Adherence of Symptomatic OLP Patients to Their Medications
Active, not recruitingPhase 4
Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus
Oral Lichen Planus
Active, not recruiting
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Objective (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07792512.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.