Oral Lichen PlanusPhase 3NCT06135259
Topical Erythropoietin Hydrogel in Management of Oral Lichen Planus
A Phase 3 study testing erythropoietin and Triamcinolone acetonide in people with Oral Lichen Planus, run by Ain Shams University.
Trial summary
The purpose of this study is to compare the clinical efficacy of erythropoietin gel containing a solution of 4000 units with triamcinolone acetonide 0.1% gel in the treatment of symptomatic oral lichen planus (OLP) 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?
- erythropoietin and Triamcinolone acetonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2024to 23 Sep 2024
- Phase
- Phase 3
- 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 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 the 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 a medical questionnaire guided by the 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 breastfeeding.
- History of previous treatments potentially effective on OLP such as antimalarial agents, retinoids, corticosteroids, or immunosuppressive drugs from less than 2 weeks for topical medications, and 4 weeks for systemic medications before starting the study
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- 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
No sites are listed yet.
About this study
Official title: Topical Erythropoietin Hydrogel in Management of Oral Lichen Planus: A Randomized Controlled Clinical Trial
The purpose of this study is to compare the clinical efficacy of erythropoietin gel containing a solution of 4000 units with triamcinolone acetonide 0.1% gel in the treatment of symptomatic oral lichen planus (OLP)
Read the detailed description
At the first visit before the initiation of the study;
- Information including age, gender, disease process, medical history, drug history, family history, and clinical symptoms and signs will be documented.
- Patients will be examined clinically by magnifying mirror using a spotlight for the oral lesions, the distribution of the lesions and the affected areas will be recorded, and a punch biopsy will be taken to confirm the diagnosis.
Twenty-four patients seeking treatment for symptomatic OLP will be assessed for eligibility for this study. Patients will be recruited from the outpatient clinic, department of Oral Medicine and Periodontology, Faculty of Dentistry, and the Department of Skin and Venereal Disease, Faculty of Medicine, Ain Shams University.
The study will be conducted according to the ethical principles provided by the Declaration of Helsinki and according to the principles of good clinical practice. Faculty of Dentistry-Ain Shams University Research Ethical Committee (FD-ASU-RECD) will review the protocol, the procedure will be fully explained to the patients. Each patient will receive detailed verbal and written information about the study protocol. Understanding and agreement to enroll in the study will be confirmed and written consent forms will be obtained.
II- Study design, interventions, blinding, randomization, and grouping:
The study is designed as a Randomized- parallel 2 arm - assessor blinded single center- controlled comparative clinical trial with immunohistochemical analysis.
- Interventions The oral Gel carrier of the intervention will be designed, prepared, and in vitro characterized at the Pharmaceutical Science Department, Faculty of Pharmacy- Ain University.
- Patients grouping Patients who met the eligibility criteria will be randomly assigned to 2 different treatment regimens using computer-generated random tables and allocation concealment;
Group I Will include twelve patients with oral lichen planus lesions receiving ( erythropoietin mucoadhesive thermosensitive hydrogel), twice daily (Experimental Arm)
Group II:
It will include twelve patients with oral lichen planus lesions receiving (Topical corticosteroid 0.1%) four times per day for 8 weeks (Positive control arm) In the fourth- and eighth both patients in group II will receive topical antifungal (Miconazole 2%) to avoid secondary candidiasis while patients in group I will receive topical antifungal only if needed
- Conditions
- Oral Lichen Planus
- Being tested
- erythropoietin, Triamcinolone acetonide
- Keywords
- erythropoietin gel, tumor necrosis factor, oral lichen planus
- 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.
erythropoietinDrug
Also called erythropoietin mucoadhesive thermosensitive hydrogel
erythropoietin solutions of 150, 300, and 500 IU/mL were mixed with trimethyl chitosan (M) solutions. glycerophosphate solution was then added to the mixture to obtain erythropoietin-loaded hydrogel comprising final concentrations of trimethyl chitosan(5%) and glycerophosphate (20%).
Triamcinolone acetonideDrug
Also called Triamcinolone Mucoadhesive gel
Each 0.1 mg triamcinolone acetonide in a dental paste containing gelatin, pectin, cream flavor, vanilla flavor and carboxymethylcellulose sodium in Plasticized Hydrocarbon Gel, a polyethylene and mineral oil gel base.
| Study group | Role | What they receive |
|---|---|---|
| erythropoietin mucoadhesive thermosensitive hydrogel | Experimental | erythropoietin solutions of 150, 300, and 500 IU/mL were mixed with trimethyl chitosan (M) solutions. glycerophosphate solution was then added to the mixture to obtain erythropoietin-loaded hydrogel comprising final concentrations of trimethyl chitosan (5%) and glycerophosphate (20%). Receives: Drug: erythropoietin |
| Triamcinolone Mucoadhesive gel | Active comparator | Each 0.1 mg triamcinolone acetonide in a dental paste containing gelatin, pectin, cream flavor, vanilla flavor and carboxymethylcellulose sodium in Plasticized Hydrocarbon Gel, a polyethylene and mineral oil gel base. Receives: Drug: Triamcinolone acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Scoring
The marker lesion in each patient will be assessed for areas of reticulation, erosion, and ulceration by visual examination and the scoring will be recorded as follow:
0: Mild represented no lesion/normal mucosa.
- White striae/no erythematous area.
- White striae with atrophic area less than 1 cm2
- White striae with atrophic area of more than 1 cm2
- White striae with an erosive area less than 1 cm2
- White striae with an erosive area of more than 1cm2
Measured: The assessment will be carried out at baseline, 1 month and 2 months after starting the treatment protocol and then at 3 months after the end of the observational period
Visual Analogue Score
The Visual Analogue Score consisted of a 10-cm horizontal line marked 0-10 (0 no pain; 10 most severe pain experienced). Patients will mark the scale at each visit. The Visual Analogue Score is then scored by measuring from the patient's mark to the beginning of the scale in cm, and all Visual Analogue Score will be included on one sheet of paper allowing the patient to think in terms of change instead of absolutes.
Measured: The assessment will be carried out at baseline, 1 month and 2 months after starting the treatment protocol and then at 3 months after the end of the observational period
Imaging and measuring surface area of the oral lesion
Standardized photographs of the oral marker lesion for each patient will be taken with the same digital camera and setting, and the surface area of the lesion will be outlined and measured using specific image software.
Measured: The assessment will be carried out at baseline, 1 and 2 months after starting the treatment protocol and then at 3 months after the end of the observational period
Secondary outcomes (1)
Tumor necrosis factor Salivary level
The patient will export 10 ml of unstimulated whole saliva into a sterile centrifuge.
tube. The saliva will be centrifuged, filtered, and frozen until use. The mean concentration of TNF-α in the 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 The patient will export 10 ml of unstimulated whole saliva into a sterile centrifuge.
tube. The saliva will be centrifuged, filtered, and frozen until use. The mean concentration of TNF-α in the 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
Measured: The Salivary Sample for each patient will be taken at baseline and after 2 months treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start20 May 2024 (estimated)
- Primary completion23 Jul 2024 (estimated)
- Study completion23 Sep 2024 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yasmine A Fouad, Ph.D, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135259
- Sponsor's protocol ID
- FDASU-RecIR022222
- Status last verified
- Apr 2023
- First submitted
- 13 Nov 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Erythropoietin Hydrogel in Management of Oral Lichen Planus: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06135259
- Acronym / sponsor ID
- FDASU-RecIR022222
- Conditions
- Oral Lichen Planus
- Keywords
- erythropoietin gel, tumor necrosis factor, oral lichen planus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 May 2024 (estimated)
- Primary completion
- 23 Jul 2024 (estimated)
- Study completion
- 23 Sep 2024 (estimated)
- First posted
- 18 Nov 2023 (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.
The purpose of this study is to compare the clinical efficacy of erythropoietin gel containing a solution of 4000 units with triamcinolone acetonide 0.1% gel in the treatment of symptomatic oral lichen planus (OLP)
Detailed description
At the first visit before the initiation of the study;
- Information including age, gender, disease process, medical history, drug history, family history, and clinical symptoms and signs will be documented.
- Patients will be examined clinically by magnifying mirror using a spotlight for the oral lesions, the distribution of the lesions and the affected areas will be recorded, and a punch biopsy will be taken to confirm the diagnosis.
Twenty-four patients seeking treatment for symptomatic OLP will be assessed for eligibility for this study. Patients will be recruited from the outpatient clinic, department of Oral Medicine and Periodontology, Faculty of Dentistry, and the Department of Skin and Venereal Disease, Faculty of Medicine, Ain Shams University.
The study will be conducted according to the ethical principles provided by the Declaration of Helsinki and according to the principles of good clinical practice. Faculty of Dentistry-Ain Shams University Research Ethical Committee (FD-ASU-RECD) will review the protocol, the procedure will be fully explained to the patients. Each patient will receive detailed verbal and written information about the study protocol. Understanding and agreement to enroll in the study will be confirmed and written consent forms will be obtained.
II- Study design, interventions, blinding, randomization, and grouping:
The study is designed as a Randomized- parallel 2 arm - assessor blinded single center- controlled comparative clinical trial with immunohistochemical analysis.
- Interventions The oral Gel carrier of the intervention will be designed, prepared, and in vitro characterized at the Pharmaceutical Science Department, Faculty of Pharmacy- Ain University.
- Patients grouping Patients who met the eligibility criteria will be randomly assigned to 2 different treatment regimens using computer-generated random tables and allocation concealment;
Group I Will include twelve patients with oral lichen planus lesions receiving ( erythropoietin mucoadhesive thermosensitive hydrogel), twice daily (Experimental Arm)
Group II:
It will include twelve patients with oral lichen planus lesions receiving (Topical corticosteroid 0.1%) four times per day for 8 weeks (Positive control arm) In the fourth- and eighth both patients in group II will receive topical antifungal (Miconazole 2%) to avoid secondary candidiasis while patients in group I will receive topical antifungal only if needed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| erythropoietin mucoadhesive thermosensitive hydrogel | Experimental | Drug: erythropoietinerythropoietin solutions of 150, 300, and 500 IU/mL were mixed with trimethyl chitosan (M) solutions. glycerophosphate solution was then added to the mixture to obtain erythropoietin-loaded hydrogel comprising final concentrations of trimethyl chitosan (5%) and glycerophosphate (20%). |
| Triamcinolone Mucoadhesive gel | Active comparator | Drug: Triamcinolone acetonideEach 0.1 mg triamcinolone acetonide in a dental paste containing gelatin, pectin, cream flavor, vanilla flavor and carboxymethylcellulose sodium in Plasticized Hydrocarbon Gel, a polyethylene and mineral oil gel base. |
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 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 (11 listed)
- History of the 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 a medical questionnaire guided by the 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 breastfeeding.
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 |
|---|---|---|
| erythropoietinAlso: erythropoietin mucoadhesive thermosensitive hydrogelerythropoietin solutions of 150, 300, and 500 IU/mL were mixed with trimethyl chitosan (M) solutions. glycerophosphate solution was then added to the mixture to obtain erythropoietin-loaded hydrogel comprising final concentrations of trimethyl chitosan(5%) and glycerophosphate (20%). | Drug | erythropoietin mucoadhesive thermosensitive hydrogel |
| Triamcinolone acetonideAlso: Triamcinolone Mucoadhesive gelEach 0.1 mg triamcinolone acetonide in a dental paste containing gelatin, pectin, cream flavor, vanilla flavor and carboxymethylcellulose sodium in Plasticized Hydrocarbon Gel, a polyethylene and mineral oil gel base. | Drug | Triamcinolone Mucoadhesive gel |
Primary outcome
Clinical Scoring
Time frame: The assessment will be carried out at baseline, 1 month and 2 months after starting the treatment protocol and then at 3 months after the end of the observational period
The marker lesion in each patient will be assessed for areas of reticulation, erosion, and ulceration by visual examination and the scoring will be recorded as follow: 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 of more than 1 cm2 4. White striae with an erosive area less than 1 cm2 5. White striae with an erosive area of more than 1cm2
Visual Analogue Score
Time frame: The assessment will be carried out at baseline, 1 month and 2 months after starting the treatment protocol and then at 3 months after the end of the observational period
The Visual Analogue Score consisted of a 10-cm horizontal line marked 0-10 (0 no pain; 10 most severe pain experienced). Patients will mark the scale at each visit. The Visual Analogue Score is then scored by measuring from the patient's mark to the beginning of the scale in cm, and all Visual Analogue Score will be included on one sheet of paper allowing the patient to think in terms of change instead of absolutes.
Imaging and measuring surface area of the oral lesion
Time frame: The assessment will be carried out at baseline, 1 and 2 months after starting the treatment protocol and then at 3 months after the end of the observational period
Standardized photographs of the oral marker lesion for each patient will be taken with the same digital camera and setting, and the surface area of the lesion will be outlined and measured using specific image software.
1 secondary outcome
Tumor necrosis factor Salivary level
Time frame: The Salivary Sample for each patient will be taken at baseline and after 2 months treatment period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
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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.
Yasmine A Fouad, Ph.D principal investigator
Ain Shams University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing erythropoietin and Triamcinolone acetonide in people with Oral Lichen Planus, run by Ain Shams University.
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: status not confirmed, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasmine A Fouad, Ph.D (01005793929, dr.yasminefouad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Scoring (time frame: The assessment will be carried out at baseline, 1 month and 2 months after starting the treatment protocol and then at 3 months after the end of the observational period). The study lists 3 primary outcomes in all. 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 1 Feb 2024.