Lichen PlanusNCT03265093
Use of Injectable Platelet Rich Fibrin in Lichen Planus
A study testing Platelet Rich Fibrin Injection and Corticosteroid in people with Lichen Planus, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Platelet Rich Fibrine (PRF), which promotes wound healing by supporting angiogenesis, immunity and epithelial proliferation phases. over a decade has since past since PRF was developed and many clinicians now point to the potential use of a liquid version of PRF. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lichen Planus
- What is being tested?
- Platelet Rich Fibrin Injection and Corticosteroid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 May 2017to 2 Sep 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Oral erosive lesions were diagnosed according to Andreasen classification.
- Histological confirmation of erosive OLP according to the World Health Organization's clinicopathological diagnostic criteria for OLP.
- No previous treatment of oral lichen planus at least 3 months.
- Willingness and ability to complete the present clinical trial.
- Patients of ages above 18 years old without skin involvement.
Who cannot join
- Histological signs of dysplasia.
- Using drugs associated with lichenoid reaction.
- Pregnant, lactating and smoker patients.
- Patient with systemic diseases such as diabetes mellitus, immunodysfunction, hematological and hepatological patients or had photosensitivity history.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Current Approach in the Treatment of Lichen Planus: Injectable Platelet Rich Fibrin ((İ-PRF)
Platelet Rich Fibrine (PRF), which promotes wound healing by supporting angiogenesis, immunity and epithelial proliferation phases. over a decade has since past since PRF was developed and many clinicians now point to the potential use of a liquid version of PRF. a liquid injectable-platelet-rich fibrin (i-PRF) was developed by modifying spin centrifugation forces. At lower centrifugation speeds and by utilizing non-glass centrifugation tubes, the fibrin coagulation could be slowed down at early time points thus generating an injectable PRF. Much like traditional PRF, i-PRF contains an increase in leukocyte number and is further able to stimulate growth factor release.
Lichen planus is a common chronic mucocutaneous inflammatory disorder which generally affect s middle aged adults. Therapeutic methods including topical and systemic corticosteroids for the treatment of oral lichen planus (OLP) are suggested. However, long
Read more
-term use of corticosteroids may be associated with local and systemic complications, and moreover, some patients may not be responsive.
The investigators aimed to apply a treatment of autogenous origin (including no foreign products), considering the side effects of our corticosteroids. The study was designed as a split mouth.
The investigators planned to administer I-PRF to one side and intralesional corticosteroid therapy to the other side at patients with bilateral atrophic / erosive oral lichen planus lesions
Read the detailed description
Lichen planus diagnosis will be made histopathologically. Intraoral photographs and measurements will be taken at the beginning of the treatment and 2 months after the treatment is finished.
- Conditions
- Lichen Planus
- Being tested
- Platelet Rich Fibrin Injection, Corticosteroid
- Keywords
- Pain Measurement, Platelet Activation, Quality of Life
- Medical subject headings
- Lichen Planus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich Fibrin InjectionOther
Venous blood will be taken from the patient every session and I-PRF will be created in the centrifuge. I- prf will be injected on one side and corticosteroid will be injected on the other side in patients with bilateral oral lichen planus. Once a week in the first month after treatment and one time at the end of the second month, the patient will be called to the control.
CorticosteroidDrug
Corticosteroid injection
| Study group | Role | What they receive |
|---|---|---|
| experimental; Corticosteroid | Active comparator | Intralesional corticosteroid administration Receives: Drug: Corticosteroid |
| Experimental; Injectable Platelet rich fibrin | Experimental | Injectable Platelet rich fibrin Receives: Other: Platelet Rich Fibrin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Patients were asked to grade the severity of their symptoms in numbers from 1(very mild pain) to 100 (very sever pain) on the visual analog scale in each visit.
Measured: 6 months
Thongprasom sign scoring system
The lesions were evaluated according to Thongprasom sign scoring system
Measured: 6 months
Oral Health- Related Quality of Life index (OHIP-14)
Patients were asked to grade the Oral Health- Related Quality of Life index
Measured: 6 months
Secondary outcomes (1)
Oral Hygiene Index
Oral Hygiene Index were evaluated.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start3 May 2017
- Primary completion2 Sep 2019
- Study completion2 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen PlanusStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Blinded, Parallel group, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ebru Sağlam, PhD, Study chair, Bezmialem Vakif UniversityMustafa Tunalı, Assoc. prof., Study director, Bezmialem VakifUniversityTuğba Ünver, PhD, Principal investigator, Bezmialem Vakif UniversityZeliha Betül Özsağır, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265093
- Sponsor's protocol ID
- EbSAGLAM2
- Status last verified
- May 2020
- First submitted
- 25 Aug 2017
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Current Approach in the Treatment of Lichen Planus: Injectable Platelet Rich Fibrin ((İ-PRF)
- ClinicalTrials.gov ID
- NCT03265093
- Acronym / sponsor ID
- EbSAGLAM2
- Conditions
- Lichen Planus
- Keywords
- Pain Measurement, Platelet Activation, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 3 May 2017 (actual)
- Primary completion
- 2 Sep 2019 (actual)
- Study completion
- 2 Sep 2019 (actual)
- First posted
- 29 Aug 2017 (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.
Platelet Rich Fibrine (PRF), which promotes wound healing by supporting angiogenesis, immunity and epithelial proliferation phases. over a decade has since past since PRF was developed and many clinicians now point to the potential use of a liquid version of PRF. a liquid injectable-platelet-rich fibrin (i-PRF) was developed by modifying spin centrifugation forces. At lower centrifugation speeds and by utilizing non-glass centrifugation tubes, the fibrin coagulation could be slowed down at early time points thus generating an injectable PRF. Much like traditional PRF, i-PRF contains an increase in leukocyte number and is further able to stimulate growth factor release.
Lichen planus is a common chronic mucocutaneous inflammatory disorder which generally affect s middle aged adults. Therapeutic methods including topical and systemic corticosteroids for the treatment of oral lichen planus (OLP) are suggested. However, long
-term use of corticosteroids may be associated with local and systemic complications, and moreover, some patients may not be responsive.
The investigators aimed to apply a treatment of autogenous origin (including no foreign products), considering the side effects of our corticosteroids. The study was designed as a split mouth.
The investigators planned to administer I-PRF to one side and intralesional corticosteroid therapy to the other side at patients with bilateral atrophic / erosive oral lichen planus lesions
Detailed description
Lichen planus diagnosis will be made histopathologically. Intraoral photographs and measurements will be taken at the beginning of the treatment and 2 months after the treatment is finished.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Blinded, Parallel group, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| experimental; Corticosteroid | Active comparator | Drug: CorticosteroidIntralesional corticosteroid administration |
| Experimental; Injectable Platelet rich fibrin | Experimental | Other: Platelet Rich Fibrin InjectionInjectable Platelet rich fibrin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Oral erosive lesions were diagnosed according to Andreasen classification.
- Histological confirmation of erosive OLP according to the World Health Organization's clinicopathological diagnostic criteria for OLP.
- No previous treatment of oral lichen planus at least 3 months.
- Willingness and ability to complete the present clinical trial.
- Patients of ages above 18 years old without skin involvement.
Key exclusion criteria (4 listed)
- Histological signs of dysplasia.
- Using drugs associated with lichenoid reaction.
- Pregnant, lactating and smoker patients.
- Patient with systemic diseases such as diabetes mellitus, immunodysfunction, hematological and hepatological patients or had photosensitivity history.
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 |
|---|---|---|
| Platelet Rich Fibrin InjectionVenous blood will be taken from the patient every session and I-PRF will be created in the centrifuge. I- prf will be injected on one side and corticosteroid will be injected on the other side in patients with bilateral oral lichen planus. Once a week in the first month after treatment and one time at the end of the second month, the patient will be called to the control. | Other | Experimental; Injectable Platelet rich fibrin |
| CorticosteroidCorticosteroid injection | Drug | experimental; Corticosteroid |
Primary outcome
Visual Analog Scale
Time frame: 6 months
Patients were asked to grade the severity of their symptoms in numbers from 1(very mild pain) to 100 (very sever pain) on the visual analog scale in each visit.
Thongprasom sign scoring system
Time frame: 6 months
The lesions were evaluated according to Thongprasom sign scoring system
Oral Health- Related Quality of Life index (OHIP-14)
Time frame: 6 months
Patients were asked to grade the Oral Health- Related Quality of Life index
1 secondary outcome
Oral Hygiene Index
Time frame: 6 months
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 May 2020.
- Individual participant dataSharing planned: Undecided
Related trials for 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
RecruitingPhase 2
A Study to Assess the Efficacy and Safety of GIA632 Across a Range of Doses in Participants With Moderate to Severe Cutaneous Lichen Planus
Cutaneous Lichen Planus
RecruitingPhase 2
Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Randomized Placebo-controlled Study.
Lichen Penis Planus
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.
Ebru Sağlam, PhD study chair
Bezmialem Vakif University
Mustafa Tunalı, Assoc. prof. study director
Bezmialem VakifUniversity
Tuğba Ünver, PhD principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Fibrin Injection and Corticosteroid in people with Lichen Planus, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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 May 2020. 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 Turkey (Türkiye). 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.
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?
Visual Analog Scale (time frame: 6 months). 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 28 May 2020.