Oral Lichen PlanusPhase 4NCT07114016
Efficacy of Topical Glucosamine Versus Corticosteroid in Oral Lichen Planus
A Phase 4 study testing Glucosamine Hydrochloride and Triamcinolone Acetonide in people with Oral Lichen Planus, run by Future University in Egypt at 1 site in Egypt.
Trial summary
Glucosamine (GlcN) is an N-deacetyl amino sugar derived from the complete hydrolysis of chitosan. It is classified as a nutraceutical and it is used mainly orally for the therapy of osteoarthritis since GlcN has immunoregulatory capacity and anti-inflammatory effects. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Glucosamine Hydrochloride and Triamcinolone Acetonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 31 Jul 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
- No healthy volunteers
- Adult
Who may be able to join
- Clinically proven painful bullous/erosive or atrophic forms of OLP
- Histopathologically proven bullous/erosive or atrophic forms of OLP
Who cannot join
- Lichenoid lesions.
- Presence of systemic conditions
- Smoking.
- Hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation as mentioned in medical history.
- Pregnancy or breast-feeding.
- Presence of skin lesions.
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- History of previous treatments potentially effective on OLP.
- Loss of pliability or flexibility in the tissues involved by the oral lesions of lichen planus.
- Histological signs of epithelial dysplasia or lichenoid lesions within the biopsied sites.
- Refusing to participate in the study.
- Vulnerable groups
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Topical Glucosamine Versus Corticosteroid on Tumor Necrosis Factor -Alpha Induced Apoptosis in Oral Lichen Planus: A Randomized Controlled Clinical Trial With Immunohistochemical Analysis
Glucosamine (GlcN) is an N-deacetyl amino sugar derived from the complete hydrolysis of chitosan. It is classified as a nutraceutical and it is used mainly orally for the therapy of osteoarthritis since GlcN has immunoregulatory capacity and anti-inflammatory effects. Given the Oral lichen planus (OLP) T-cell-mediated pathogenesis; this drug seems to be a promising therapeutic option. The investigators compared the clinical efficacy of topical glucosamine to topical corticosteroid in the treatment of symptomatic OLP and investigated the effect of these two treatment modalities on the expression of tumor necrosis factor-alpha (TNF-α) in oral lichen planus lesions
Read the detailed description
Thirty-six patients with erosive or atrophic OLP were randomly assigned into Two equal groups to receive topical GlcN (glucosamine hydrochloride 1%) 4 times/day for 8 weeks (Group I) and topical steroid (triamcinolone acetonide 0.1 %) 4 times / day for 8 weeks (Group II). All patients were followed up for another 4 weeks (treatment free observational period). Photographs of the most severe lesion were taken (Marker lesion) in each patient and analyzed for total surface area (TSA), total ulcerative area (TUA), total atrophic area (TAA), and total papular area (TPA), patients were also assessed using clinical scores (CS) and visual analogue scale (VAS). Pre-treatment and post-treatment specimens were immunohistochemically analyzed to detect expression of TNF-α.
- Conditions
- Oral Lichen Planus
- Being tested
- Glucosamine Hydrochloride, Triamcinolone Acetonide
- Keywords
- GlcN.H
- 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.
Glucosamine HydrochlorideDrug
GlcN.H is an N-deacetyl amino sugar derived from the complete hydrolysis of chitosan known for its immunoregulatory capacity and anti-inflammatory effects.
Triamcinolone AcetonideDrug
Topical corticosteroid (triamcinolone acetonide is a synthetic corticosteroid with potent anti-inflammatory, anti-allergic, and immunosuppressive properties which is used commonly in topical formulations)
| Study group | Role | What they receive |
|---|---|---|
| Glucosamine | Experimental | (Topical glucosamine hydrochloride 1%) Four times per day for 8 weeks Receives: Drug: Glucosamine Hydrochloride |
| Corticosteroids | Active comparator | Topical steroid (triamcinolone acetonide 0.1 %) four times per day for 8 weeks Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical score (CS)
"0" represented no lesion/normal mucosa; "1" mild 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 less than 1 cm², and "5" white striae with erosive area more than 1 cm²
Measured: Change from Baseline at 12 weeks
Secondary outcomes (1)
TNF-α
TNF-α is a highly pleiotropic multifunctional cytokine. It plays a prominent role in host defense and immune responses to infection, influences remodeling of tissue, angiogenesis stimulation and takes part in regulation of cell proliferation and differentiation. It has been known as an important mediator of cancer
Measured: Change from baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 May 2023
- Primary completion15 May 2025
- Study completion31 Jul 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.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Abd El-Halim Galala, Future University in Egypt
- Investigators
- Nevine H Kheir El Din, Prof., Study director, Faculty of Dentistry-ASU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114016
- Sponsor's protocol ID
- FDASU-REC0787
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Age, gender and the number of the participants
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topical Glucosamine Versus Corticosteroid on Tumor Necrosis Factor -Alpha Induced Apoptosis in Oral Lichen Planus: A Randomized Controlled Clinical Trial With Immunohistochemical Analysis
- ClinicalTrials.gov ID
- NCT07114016
- Acronym / sponsor ID
- FDASU-REC0787
- Conditions
- Oral Lichen Planus
- Keywords
- GlcN.H
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 11 Aug 2025 (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.
Glucosamine (GlcN) is an N-deacetyl amino sugar derived from the complete hydrolysis of chitosan. It is classified as a nutraceutical and it is used mainly orally for the therapy of osteoarthritis since GlcN has immunoregulatory capacity and anti-inflammatory effects. Given the Oral lichen planus (OLP) T-cell-mediated pathogenesis; this drug seems to be a promising therapeutic option. The investigators compared the clinical efficacy of topical glucosamine to topical corticosteroid in the treatment of symptomatic OLP and investigated the effect of these two treatment modalities on the expression of tumor necrosis factor-alpha (TNF-α) in oral lichen planus lesions
Detailed description
Thirty-six patients with erosive or atrophic OLP were randomly assigned into Two equal groups to receive topical GlcN (glucosamine hydrochloride 1%) 4 times/day for 8 weeks (Group I) and topical steroid (triamcinolone acetonide 0.1 %) 4 times / day for 8 weeks (Group II). All patients were followed up for another 4 weeks (treatment free observational period). Photographs of the most severe lesion were taken (Marker lesion) in each patient and analyzed for total surface area (TSA), total ulcerative area (TUA), total atrophic area (TAA), and total papular area (TPA), patients were also assessed using clinical scores (CS) and visual analogue scale (VAS). Pre-treatment and post-treatment specimens were immunohistochemically analyzed to detect expression of TNF-α.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucosamine | Experimental | Drug: Glucosamine Hydrochloride(Topical glucosamine hydrochloride 1%) Four times per day for 8 weeks |
| Corticosteroids | Active comparator | Drug: Triamcinolone AcetonideTopical steroid (triamcinolone acetonide 0.1 %) four times per day for 8 weeks |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinically proven painful bullous/erosive or atrophic forms of OLP
- Histopathologically proven bullous/erosive or atrophic forms of OLP
Key exclusion criteria (11 listed)
- Lichenoid lesions.
- Presence of systemic conditions
- Smoking.
- Hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation as mentioned in medical 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 |
|---|---|---|
| Glucosamine HydrochlorideGlcN.H is an N-deacetyl amino sugar derived from the complete hydrolysis of chitosan known for its immunoregulatory capacity and anti-inflammatory effects. | Drug | Glucosamine |
| Triamcinolone AcetonideTopical corticosteroid (triamcinolone acetonide is a synthetic corticosteroid with potent anti-inflammatory, anti-allergic, and immunosuppressive properties which is used commonly in topical formulations) | Drug | Corticosteroids |
Primary outcome
Clinical score (CS)
Time frame: Change from Baseline at 12 weeks
"0" represented no lesion/normal mucosa; "1" mild 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 less than 1 cm², and "5" white striae with erosive area more than 1 cm²
1 secondary outcome
TNF-α
Time frame: Change from baseline at 8 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 17 Aug 2025.
- Individual participant dataSharing planned: Yes. Age, gender and the number of the participants
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Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
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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.
Nevine H Kheir El Din, Prof. study director
Faculty of Dentistry-ASU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glucosamine Hydrochloride and Triamcinolone Acetonide in people with Oral Lichen Planus, run by Future University in Egypt at 1 site in Egypt.
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 2 inclusion and 11 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 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Clinical score (CS) (time frame: Change from Baseline at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2025.