Erosive Oral Lichen PlanusPhase 2NCT03293368
Efficacy of Intralesional Injection of Platelet Rich Plasma in the Treatment of Patients With Erosive Oral Lichen Planus
A Phase 2 study testing Platelet rich plasma and Triamcinolone Acetonide in people with Erosive Oral Lichen Planus, run by Cairo University at 1 site in Egypt.
Trial summary
After signing the informed consent, the participant will be allocated to either intervention or control group, then each participant in the intervention group will receive intralesional injections of platelet rich plasma extracted from their own blood in each visit as following: 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Erosive Oral Lichen Planus
- What is being tested?
- Platelet rich plasma and Triamcinolone Acetonide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Jan 2021
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients presenting with a clinical picture that assumes the diagnosis of erosive oral lichen planus (bilateral, more or less symmetrical erosive lesions with lacelike network of slightly raised gray white lesions (reticular pattern), and a histological findings that confirms the diagnosis (liquefaction degeneration of the basal cell layer with irregular-saw teeth like rete pegs.
Who cannot join
- Systemic disorders such as hematological diseases, severe cardiovascular diseases, treatment with any drugs that could cause Lichenoid reaction.
- Pregnancy or active breastfeeding
- Patients who had lesion/lesions with dysplasia
- Patients who received topical treatment for Oral Lichen planus in the last 2 weeks (Lee et al., 2013) or systemic treatment for OLP in the past 3 months.
- Platelet count < 150,000/mm3; Hgb < 11 g/dl.
- Immunosuppressed patients
- Patients receiving therapy with anticoagulants and use of non-steroidal anti-inflammatory drugs in the 5 days before taking the blood sample.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Intralesional Injection of Autologous Platelet Rich Plasma Versus Intralesional Injection of Corticosteroids on Pain Relief and Ulcers Healing in Patients With Erosive Oral Lichen Planus; Randomized Clinical Trial
After signing the informed consent, the participant will be allocated to either intervention or control group, then each participant in the intervention group will receive intralesional injections of platelet rich plasma extracted from their own blood in each visit as following:
- 12 ml of blood will be assembled from the veins of antecubital fossa
- PRP preparation will be done according to Mostafa et al., 2013
- 0.5 ml of PRP will be injected per 1 cm2 of ulcerated mucosa
Read more
The second group will receive triamcinolone acetonide 40 mg injected 1 ml per 1 cm2 of ulcerated mucosa
Both groups will receive a total of 4 injection, the injections will be carried out once a week.
Pain, lesions size and remission time are the outcomes will be assessed using a numerical rating scale (Seymour, 1982), clinical score according to Thongprasom et al., 1992 and binary scale for remission time according to Conrotto et al., 2006, respectively.
Assessment of the outcomes will be carried before the trial (baseline records) and before receiving the treatment in each visit by the primary investigator (H.A.) and the blinded assessor (Dr. A.W.) separately.
Each participant will have a total of 11 visits during the trial, 5 visits will be once every week during the trial and every 2 weeks for 3 months treatment free.
- Conditions
- Erosive Oral Lichen Planus
- Being tested
- Platelet rich plasma, Triamcinolone Acetonide
- Keywords
- Oral, Lichen planus, PRP
- 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 plasmaBiological
Also called Platelet rich in growth factors
Platelet rich plasma will be prepared from the patients own blood in the same visit using a double spin technique, then 0.5 ml of PRP will be injected per 1 cm2 of eroded oral mucosa.
Triamcinolone AcetonideDrug
Also called Corticosteroids, Steroids
0.5 ml of triamcinolone acetonide 40mg will be injected per 1 cm2 of eroded oral mucosa
| Study group | Role | What they receive |
|---|---|---|
| Platelet rich plasma | Experimental | 0.5 ml of autologous platelet rich plasma prepared using a double spin technique described by Mostafa et al., 2013 will be injected in the center of eroded oral mucosa in patients suffering from oral lichen planus. Receives: Biological: Platelet rich plasma |
| Croticosteroids | Active comparator | 0.5 ml of triamcinolone acetonide 40 mg will be injected in the center of eroded oral mucosa in patients suffering from oral lichen planus. Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reported Pain
Pain and burning sensation assessed using Numerical rating scale
Measured: 3 months
Secondary outcomes (2)
Clinical score
Clinical score using a 5 grades scoring system described by Thongprasom et al.,1992
Measured: 3 months
Remission time
Time until flare up of the disease occur using a binary scale (Stable/Not stable) described by Conrotto et al., 2006
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start1 Jan 2018
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erosive Oral Lichen PlanusStudies of the same condition, open and under way.
- More trials run by Cairo 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelhameed Hamid Mohammad Hijazi, Cairo University
- Investigators
- Soheir Gaafar, Professor, Study chair, Professor of oral medicine, diagnosis and periodontology. Faculty of Dentistry. Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293368
- Sponsor's protocol ID
- PRP-olp
- Status last verified
- Feb 2023
- First submitted
- 19 Sep 2017
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hijazi A, Ahmed W, Gaafar S. Efficacy of intralesional injections of platelet-rich plasma in patients with oral lichen planus: A pilot randomized clinical trial. Clin Exp Dent Res. 2022 Jun;8(3):707-714. doi: 10.1002/cre2.550. Epub 2022 Feb 26.
PubMed 35218680
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intralesional Injection of Autologous Platelet Rich Plasma Versus Intralesional Injection of Corticosteroids on Pain Relief and Ulcers Healing in Patients With Erosive Oral Lichen Planus; Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03293368
- Acronym / sponsor ID
- PRP-olp
- Conditions
- Erosive Oral Lichen Planus
- Keywords
- Oral, Lichen planus, PRP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 26 Sep 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.
After signing the informed consent, the participant will be allocated to either intervention or control group, then each participant in the intervention group will receive intralesional injections of platelet rich plasma extracted from their own blood in each visit as following:
- 12 ml of blood will be assembled from the veins of antecubital fossa
- PRP preparation will be done according to Mostafa et al., 2013
- 0.5 ml of PRP will be injected per 1 cm2 of ulcerated mucosa
The second group will receive triamcinolone acetonide 40 mg injected 1 ml per 1 cm2 of ulcerated mucosa
Both groups will receive a total of 4 injection, the injections will be carried out once a week.
Pain, lesions size and remission time are the outcomes will be assessed using a numerical rating scale (Seymour, 1982), clinical score according to Thongprasom et al., 1992 and binary scale for remission time according to Conrotto et al., 2006, respectively.
Assessment of the outcomes will be carried before the trial (baseline records) and before receiving the treatment in each visit by the primary investigator (H.A.) and the blinded assessor (Dr. A.W.) separately.
Each participant will have a total of 11 visits during the trial, 5 visits will be once every week during the trial and every 2 weeks for 3 months treatment free.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet rich plasma | Experimental | Biological: Platelet rich plasma0.5 ml of autologous platelet rich plasma prepared using a double spin technique described by Mostafa et al., 2013 will be injected in the center of eroded oral mucosa in patients suffering from oral lichen planus. |
| Croticosteroids | Active comparator | Drug: Triamcinolone Acetonide0.5 ml of triamcinolone acetonide 40 mg will be injected in the center of eroded oral mucosa in patients suffering from oral lichen planus. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presenting with a clinical picture that assumes the diagnosis of erosive oral lichen planus (bilateral, more or less symmetrical erosive lesions with lacelike network of slightly raised gray white lesions (reticular pattern), and a histological findings that confirms the diagnosis (liquefaction degeneration of the basal cell layer with irregular-saw teeth like rete pegs.
Key exclusion criteria (7 listed)
- Systemic disorders such as hematological diseases, severe cardiovascular diseases, treatment with any drugs that could cause Lichenoid reaction.
- Pregnancy or active breastfeeding
- Patients who had lesion/lesions with dysplasia
- Patients who received topical treatment for Oral Lichen planus in the last 2 weeks (Lee et al., 2013) or systemic treatment for OLP in the past 3 months.
- Platelet count < 150,000/mm3; Hgb < 11 g/dl.
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 plasmaAlso: Platelet rich in growth factorsPlatelet rich plasma will be prepared from the patients own blood in the same visit using a double spin technique, then 0.5 ml of PRP will be injected per 1 cm2 of eroded oral mucosa. | Biological | Platelet rich plasma |
| Triamcinolone AcetonideAlso: Corticosteroids, Steroids0.5 ml of triamcinolone acetonide 40mg will be injected per 1 cm2 of eroded oral mucosa | Drug | Croticosteroids |
Primary outcome
Reported Pain
Time frame: 3 months
Pain and burning sensation assessed using Numerical rating scale
2 secondary outcomes
Clinical score
Time frame: 3 months
Remission time
Time frame: 3 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 9 Feb 2023.
- Derived from this study: PubMed 35218680Hijazi A, Ahmed W, Gaafar S. Efficacy of intralesional injections of platelet-rich plasma in patients with oral lichen planus: A pilot randomized clinical trial. Clin Exp Dent Res. 2022 Jun;8(3):707-714. doi: 10.1002/cre2.550. Epub 2022 Feb 26.
- Individual participant dataSharing planned: Undecided
Related trials for Erosive Oral Lichen Planus
Not yet recruiting
Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
Oral Lichen Planus
Recruiting
Photobiomodulation, Photodynamic Therapy, and Clobetasol in the Treatment of Oral Lichen Planus.
Oral Lichen Planus, Erosive Lichen Planus
Recruiting
The Therapeutic Effect of Curcumin in Nanogels Compared to 0.1% FAO in the Management of Oral Lichen Planus
Oral Lichen Planus
RecruitingPhase 1/2
Evaluation of the Efficacy of 0.08% Tacrolimus Nanoencapsulated Aqueous Solution Spray Vs. 0.1% Free Tacrolimus Commercial Ointment in the Treatment of Oral Lichen Planus
Oral Erosive Lichen Planus
Not yet recruiting
Periodontal Initial Treatment Combined With Glucocorticoid Therapy for Erosive Oral Lichen Planus
Oral Lichen Planus, Periodontal Diseases
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.
Soheir Gaafar, Professor study chair
Professor of oral medicine, diagnosis and periodontology. Faculty of Dentistry. Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Platelet rich plasma and Triamcinolone Acetonide in people with Erosive Oral Lichen Planus, run by Cairo University 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 1 inclusion and 7 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 9 Feb 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Reported Pain (time frame: 3 months). 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 NCT03293368, which also lists 1 linked publication.
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 9 Feb 2023.