Oral Pemphigus VulgarisPhase 3NCT02828163
Comparison Between Injections of Steroids and Autologous Platelet Rich Plasma in the Oral Erosions of Pemphigus Vulgaris
A Phase 3 study testing Autologous Platelet rich plasma and Triamcinolone Acetonide in people with Oral Pemphigus Vulgaris, run by Cairo University at 1 site in Egypt.
Trial summary
Comparing the effect of injecting autologous platelet rich plasma and triamcinolone acetonide in the erosions of buccal mucosa of pemphigus vulgaris patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oral Pemphigus Vulgaris
- What is being tested?
- Autologous Platelet rich plasma and Triamcinolone Acetonide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Oct 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pemphigus vulgaris patients having bilateral erosions in the buccal mucosa.
Who cannot join
- Pemphigus vulgaris patients who do not have oral erosions.
- Pemphigus vulgaris patients who have received intralesional steroid injection in their buccal mucosa.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine Cairo University Dermatology Department
Cairo, Please Select, 11956
About this study
Official title: Comparative Study Between Intralesional Autologous Platelet Rich Plasma and Intralesional Triamcinolone Acetonide in the Oral Erosions of Pemphigus Vulgaris Patients
Comparing the effect of injecting autologous platelet rich plasma and triamcinolone acetonide in the erosions of buccal mucosa of pemphigus vulgaris patients.
Read the detailed description
Ten (Pemphigus vulgaris (PV) patients will be enrolled in this study. The clinical disease score of the patients will be assessed using the pemphigus disease area index (PDAI). Three milliliters of blood will be withdrawn from each patient. The blood will be centrifuged and the platelet rich plasma (PRP) will be extracted. Patients will receive autologous PRP injections for one side of buccal mucosa and triamcinolone acetonide 10mg/ml at the other buccal mucosa at biweekly intervals for 3 months. The degree of pain and clinical improvement of each buccal mucosa will be assessed by an investigator who does not know the nature of injection in each buccal mucosa. Therefore the investigation doing the injection will not be blind but the other investigator assessing the results will be blind also the patients will be blind.
- Conditions
- Oral Pemphigus Vulgaris
- Being tested
- Autologous Platelet rich plasma, Triamcinolone Acetonide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Platelet rich plasmaOther
Also called autologous PRP
Intralesional injection of 1 milliliter of autologous Platelet rich plasma in the oral erosions every 2 weeks for 3 months.
Triamcinolone AcetonideDrug
Also called Kenacort
10mg/ml of Triamcinolone acetonide will be injected in one side of the oral mucosa of pemphigus vulgaris patients every 2 weeks for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Platelet rich plasma | Experimental | Autologous platelet-rich plasma (PRP) is autologous plasma that has platelet concentration above the baseline. 1 millilitre of autologous platelet-rich plasma will be injected in one side of the oral mucosa of pemphigus vulgaris patients every 2 weeks for 3 months. Receives: Other: Autologous Platelet rich plasma |
| Triamcinolone acetonide | Active comparator | Triamcinolone acetonide is an effective treatment for oral erosions of pemphigus vulgaris patients. 10mg/ml of Triamcinolone acetonide will be injected in one side of the oral mucosa of pemphigus vulgaris patients every 2 weeks for 3 months. Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of the size of oral erosions.
These observations will be performed at start and end of treatment period by evaluating patients's photos by two blinded observers. The clinically measured score of improvement will be recorded by both observers. Score of improvement is defined as 0-25% clinical improvement of ulcers = poor response to treatment, 26-50% clinical improvement of ulcers = average response, 51-75% clinical improvement of ulcers = good response, >75% excellent response
Measured: 3 months
Improvement of the depth of oral erosions.
Measured: 3 months
Improvement of the degree of erythema of oral erosions.
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 posted11 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oral Pemphigus VulgarisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwah Adly Saleh, Cairo University
- Investigators
- Mohamed HM EL-Komy, M.D, Study chair, Dermatology Department Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828163
- Sponsor's protocol ID
- PRP # steroids in pemphigus
- Status last verified
- Mar 2017
- First submitted
- 27 Jun 2016
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
EL-Komy MH, Hassan AS, Abdel Raheem HM, Doss SS, EL-Kaliouby M, Saleh NA, Saleh MA. Platelet-rich plasma for resistant oral erosions of pemphigus vulgaris: A pilot study. Wound Repair Regen. 2015 Nov-Dec;23(6):953-5. doi: 10.1111/wrr.12363. Epub 2015 Nov 4.
PubMed 26340377Saleh MA. Pemphigus in the Arab world. J Dermatol. 2015 Jan;42(1):27-30. doi: 10.1111/1346-8138.12676.
PubMed 25558949Mignogna MD, Fortuna G, Leuci S, Adamo D, Dell'Aversana Orabona G, Ruoppo E. Adjuvant triamcinolone acetonide injections in oro-pharyngeal pemphigus vulgaris. J Eur Acad Dermatol Venereol. 2010 Oct;24(10):1157-65. doi: 10.1111/j.1468-3083.2010.03610.x.
PubMed 20236381
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Intralesional Autologous Platelet Rich Plasma and Intralesional Triamcinolone Acetonide in the Oral Erosions of Pemphigus Vulgaris Patients
- ClinicalTrials.gov ID
- NCT02828163
- Acronym / sponsor ID
- PRP # steroids in pemphigus
- Conditions
- Oral Pemphigus Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 11 Jul 2016 (estimated)
- 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.
Comparing the effect of injecting autologous platelet rich plasma and triamcinolone acetonide in the erosions of buccal mucosa of pemphigus vulgaris patients.
Detailed description
Ten (Pemphigus vulgaris (PV) patients will be enrolled in this study. The clinical disease score of the patients will be assessed using the pemphigus disease area index (PDAI). Three milliliters of blood will be withdrawn from each patient. The blood will be centrifuged and the platelet rich plasma (PRP) will be extracted. Patients will receive autologous PRP injections for one side of buccal mucosa and triamcinolone acetonide 10mg/ml at the other buccal mucosa at biweekly intervals for 3 months. The degree of pain and clinical improvement of each buccal mucosa will be assessed by an investigator who does not know the nature of injection in each buccal mucosa. Therefore the investigation doing the injection will not be blind but the other investigator assessing the results will be blind also the patients will be blind.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous Platelet rich plasma | Experimental | Other: Autologous Platelet rich plasmaAutologous platelet-rich plasma (PRP) is autologous plasma that has platelet concentration above the baseline. 1 millilitre of autologous platelet-rich plasma will be injected in one side of the oral mucosa of pemphigus vulgaris patients every 2 weeks for 3 months. |
| Triamcinolone acetonide | Active comparator | Drug: Triamcinolone AcetonideTriamcinolone acetonide is an effective treatment for oral erosions of pemphigus vulgaris patients. 10mg/ml of Triamcinolone acetonide will be injected in one side of the oral mucosa of pemphigus vulgaris patients every 2 weeks for 3 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pemphigus vulgaris patients having bilateral erosions in the buccal mucosa.
Key exclusion criteria (2 listed)
- Pemphigus vulgaris patients who do not have oral erosions.
- Pemphigus vulgaris patients who have received intralesional steroid injection in their buccal mucosa.
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 |
|---|---|---|
| Autologous Platelet rich plasmaAlso: autologous PRPIntralesional injection of 1 milliliter of autologous Platelet rich plasma in the oral erosions every 2 weeks for 3 months. | Other | Autologous Platelet rich plasma |
| Triamcinolone AcetonideAlso: Kenacort10mg/ml of Triamcinolone acetonide will be injected in one side of the oral mucosa of pemphigus vulgaris patients every 2 weeks for 3 months. | Drug | Triamcinolone acetonide |
Primary outcome
Improvement of the size of oral erosions.
Time frame: 3 months
These observations will be performed at start and end of treatment period by evaluating patients's photos by two blinded observers. The clinically measured score of improvement will be recorded by both observers. Score of improvement is defined as 0-25% clinical improvement of ulcers = poor response to treatment, 26-50% clinical improvement of ulcers = average response, 51-75% clinical improvement of ulcers = good response, >75% excellent response
Improvement of the depth of oral erosions.
Time frame: 3 months
Improvement of the degree of erythema of oral erosions.
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 3 Mar 2017.
- Background: PubMed 26340377EL-Komy MH, Hassan AS, Abdel Raheem HM, Doss SS, EL-Kaliouby M, Saleh NA, Saleh MA. Platelet-rich plasma for resistant oral erosions of pemphigus vulgaris: A pilot study. Wound Repair Regen. 2015 Nov-Dec;23(6):953-5. doi: 10.1111/wrr.12363. Epub 2015 Nov 4.
- Background: PubMed 25558949Saleh MA. Pemphigus in the Arab world. J Dermatol. 2015 Jan;42(1):27-30. doi: 10.1111/1346-8138.12676.
- Background: PubMed 20236381Mignogna MD, Fortuna G, Leuci S, Adamo D, Dell'Aversana Orabona G, Ruoppo E. Adjuvant triamcinolone acetonide injections in oro-pharyngeal pemphigus vulgaris. J Eur Acad Dermatol Venereol. 2010 Oct;24(10):1157-65. doi: 10.1111/j.1468-3083.2010.03610.x.
- Individual participant dataSharing planned: Undecided
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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.
Mohamed HM EL-Komy, M.D study chair
Dermatology Department 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 3 study testing Autologous Platelet rich plasma and Triamcinolone Acetonide in people with Oral Pemphigus Vulgaris, 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 2 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 3 Mar 2017. 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 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?
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?
Improvement of the size of oral erosions. (time frame: 3 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?
On the ClinicalTrials.gov record for NCT02828163, which also lists 3 linked publications.
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 3 Mar 2017; AzTrials last refreshed its copy on 8 Nov 2026.