Oral Ulcer Due to Pemphius VularisPhase 1NCT03878771
PRF in Management of Chronic Multiple Oral Ulcers
A Phase 1 study testing Platelet rich fibrin gel in Orabase and Dermovate cream in Orabase in people with Oral Ulcer Due to Pemphius Vularis and Oral Ulcer Due to Benign Mucous Membrane Pemphioid, run by Beni-Suef University at 1 site in Egypt.
Trial summary
PRF in orabase will be applied as a pack material on chronic oral ulcers of chronic multiple oral lesions compared to conventional topical steroid therapy with clobetasol propionate 0.05% in orabase. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oral Ulcer Due to Pemphius Vularis, Oral Ulcer Due to Benign Mucous Membrane Pemphioid, Oral Ulcer Due to Steven Johnson's Syndrome
- What is being tested?
- Platelet rich fibrin gel in Orabase and Dermovate cream in Orabase
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 804 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Mar 2019to 15 Apr 2019
- Phase
- Phase 1
- 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 with Oral ulcers due to Benin mucous membrane pemphioid, Pemphius vulgaris and Steven Johnson's Syndrome with mucositis score 4 and pain score 10
Who cannot join
- patients with any systemic other systemic condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Platelet Rich-plasma in Management of Chronic Multiple Oral Ulcers
PRF in orabase will be applied as a pack material on chronic oral ulcers of chronic multiple oral lesions compared to conventional topical steroid therapy with clobetasol propionate 0.05% in orabase. The outcomes measured are Pain alleviation as Primary outcome and Clinical improvement in terms of Ulcer size, Number and Mucositis score as Secondary outcomes. Time frame for outcomes assessment will be Daily for 7 Days regarding pain score and weekly for 2 weeks regarding clinical improvement.
Read the detailed description
The management of oral ulcers and mucositis specially the resistant types such as oral ulcers due to auto-immune diseases is a major concern by the dentists through all the world. Topical corticosteroids, analgesics, Laser bio modulation all have been proposed as treatments with limited efficacy in many cases. There are few number of clinical trials on Plasma preparation in management of oral mucositis and oral ulcers. Platelet rich fibrin (PRF) is one of the platelet concentrates. The preparation protocol of PRF is simple and easy, could be prepared autologous and immediately placed on the oral ulcers and mucositis.
Subjects and Methods: A non Randomized clinical trial will be conducted. Ten patients with different resistant oral ulcers and mucositis were enrolled. all with grade 4 WHO mucositis score. The initial numerical ratting score of pain is 10. For all patients 20 ml blood sample will obtained in plain blood vacutainer, centrifuged for 15 minutes on 3000 rpm. The resultant gel, obtained and squeezed to prepare a membrane, the membrane will be mixed with orabase and placed over the oral ulcers and mucositis over a piece of gauze. The patients will be instructed not to eat or drink for 2 hours after application. The remaining serum after squeezing was mixed with equal amount of orabase and used topically on the oral mucositis and ulcers.
Clobetasol Propionate 0.05% in orabase will be applied to 10 control patients 3 times per day for one week.
The steps will be repeated after one week if the patients' symptomatic scores for WHO and numerical rating score were not zero.
- Conditions
- Oral Ulcer Due to Pemphius Vularis, Oral Ulcer Due to Benign Mucous Membrane Pemphioid, Oral Ulcer Due to Steven Johnson's Syndrome
- Being tested
- Platelet rich fibrin gel in Orabase, Dermovate cream in Orabase
- Keywords
- Platelet rich fibrin, Oral Ulcer, Pain, Mucositis
- Medical subject headings
- Oral Ulcer, Pain, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich fibrin gel in OrabaseBiological
Also called autologus PRF gel
applied on oral mucositis and /or ulcer 3 times per day
Dermovate cream in OrabaseDrug
Also called Clobetasol Propionate 0.05%
applied on oral mucositis and /or ulcer 3 times per day
| Study group | Role | What they receive |
|---|---|---|
| autologous Platelet rich fibrin in Orabase (PRF) | Experimental | applied to oral ulcer and/or mucositis 3 times per day Receives: Biological: Platelet rich fibrin gel in Orabase |
| Clobetasol propionate 0.05%(Dermovate cream) in orabase | Active comparator | applied to oral ulcer and/or mucositis 3 times per day Receives: Drug: Dermovate cream in Orabase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Numerical Rating score of Pain, graded from 0 to 10, were 0 is no pain at all and 10 represent severe pain, obtaining lower values reflects improvement
Measured: 1 week
Secondary outcomes (3)
Mucositis
WHO mucositis score, graded from 0 to 4 were 0 no mucositis and 4 severe mucositis, obtaining lower values reflects improvement
Measured: 2 weeks
ulcer size
Measurement in cm for the largest ulcer, expressed as maximum height x maximum width reflecting the average size, decrease in size is improvement
Measured: 2 weeks
ulcer number
number counted for each patient, decrease in number reflects improvement
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start13 Mar 2019
- Primary completion15 Apr 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Ulcer Due to Pemphius VularisStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients with chronic multiple oral lesions due to benign mucous membrane Pemphigoid, Pemphigus vulgaris, ans Steven Johnson's Syndrome
- Masking
- None (open label)
- Enrolment
- 804 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Magdy Ahmed, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878771
- Sponsor's protocol ID
- 00uad
- Status last verified
- Sep 2020
- First submitted
- 13 Mar 2019
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich-plasma in Management of Chronic Multiple Oral Ulcers
- ClinicalTrials.gov ID
- NCT03878771
- Acronym / sponsor ID
- 00uad
- Conditions
- Oral Ulcer Due to Pemphius Vularis, Oral Ulcer Due to Benign Mucous Membrane Pemphioid, Oral Ulcer Due to Steven Johnson's Syndrome
- Keywords
- Platelet rich fibrin, Oral Ulcer, Pain, Mucositis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 804 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 18 Mar 2019 (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.
PRF in orabase will be applied as a pack material on chronic oral ulcers of chronic multiple oral lesions compared to conventional topical steroid therapy with clobetasol propionate 0.05% in orabase. The outcomes measured are Pain alleviation as Primary outcome and Clinical improvement in terms of Ulcer size, Number and Mucositis score as Secondary outcomes. Time frame for outcomes assessment will be Daily for 7 Days regarding pain score and weekly for 2 weeks regarding clinical improvement.
Detailed description
The management of oral ulcers and mucositis specially the resistant types such as oral ulcers due to auto-immune diseases is a major concern by the dentists through all the world. Topical corticosteroids, analgesics, Laser bio modulation all have been proposed as treatments with limited efficacy in many cases. There are few number of clinical trials on Plasma preparation in management of oral mucositis and oral ulcers. Platelet rich fibrin (PRF) is one of the platelet concentrates. The preparation protocol of PRF is simple and easy, could be prepared autologous and immediately placed on the oral ulcers and mucositis.
Subjects and Methods: A non Randomized clinical trial will be conducted. Ten patients with different resistant oral ulcers and mucositis were enrolled. all with grade 4 WHO mucositis score. The initial numerical ratting score of pain is 10. For all patients 20 ml blood sample will obtained in plain blood vacutainer, centrifuged for 15 minutes on 3000 rpm. The resultant gel, obtained and squeezed to prepare a membrane, the membrane will be mixed with orabase and placed over the oral ulcers and mucositis over a piece of gauze. The patients will be instructed not to eat or drink for 2 hours after application. The remaining serum after squeezing was mixed with equal amount of orabase and used topically on the oral mucositis and ulcers.
Clobetasol Propionate 0.05% in orabase will be applied to 10 control patients 3 times per day for one week.
The steps will be repeated after one week if the patients' symptomatic scores for WHO and numerical rating score were not zero.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with chronic multiple oral lesions due to benign mucous membrane Pemphigoid, Pemphigus vulgaris, ans Steven Johnson's Syndrome
| Arm | Type | Receives |
|---|---|---|
| autologous Platelet rich fibrin in Orabase (PRF) | Experimental | Biological: Platelet rich fibrin gel in Orabaseapplied to oral ulcer and/or mucositis 3 times per day |
| Clobetasol propionate 0.05%(Dermovate cream) in orabase | Active comparator | Drug: Dermovate cream in Orabaseapplied to oral ulcer and/or mucositis 3 times per day |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Oral ulcers due to Benin mucous membrane pemphioid, Pemphius vulgaris and Steven Johnson's Syndrome with mucositis score 4 and pain score 10
Key exclusion criteria (1 listed)
- patients with any systemic other systemic condition
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 gel in OrabaseAlso: autologus PRF gelapplied on oral mucositis and /or ulcer 3 times per day | Biological | autologous Platelet rich fibrin in Orabase (PRF) |
| Dermovate cream in OrabaseAlso: Clobetasol Propionate 0.05%applied on oral mucositis and /or ulcer 3 times per day | Drug | Clobetasol propionate 0.05%(Dermovate cream) in orabase |
Primary outcome
Pain score
Time frame: 1 week
Numerical Rating score of Pain, graded from 0 to 10, were 0 is no pain at all and 10 represent severe pain, obtaining lower values reflects improvement
3 secondary outcomes
Mucositis
Time frame: 2 weeks
ulcer size
Time frame: 2 weeks
ulcer number
Time frame: 2 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 7 Sep 2020.
- Individual participant dataSharing planned: Yes
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Platelet rich fibrin gel in Orabase and Dermovate cream in Orabase in people with Oral Ulcer Due to Pemphius Vularis and Oral Ulcer Due to Benign Mucous Membrane Pemphioid, run by Beni-Suef 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 1 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 7 Sep 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pain score (time frame: 1 week). 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 7 Sep 2020.