Comparison Between Injections of Steroids and Autologous Platelet Rich Plasma in the Oral Erosions of Pemphigus Vulgaris

Study Overview
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Brief Summary
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Comparing the effect of injecting autologous platelet rich plasma and triamcinolone acetonide in the erosions of buccal mucosa of pemphigus vulgaris patients.

Detailed Description
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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 Three milliliters of blood will be withdrawn from each patient.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.

Official Title
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Comparative Study Between Intralesional Autologous Platelet Rich Plasma and Intralesional Triamcinolone Acetonide in the Oral Erosions of Pemphigus Vulgaris Patients

Conditions
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Oral Pemphigus Vulgaris

Intervention / Treatment
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* Other: Autologous Platelet rich plasma
* Drug: Triamcinolone Acetonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pemphigus vulgaris patients having bilateral erosions in the buccal mucosa. Exclusion Criteria: Pemphigus vulgaris patients who do not have oral erosions. Pemphigus vulgaris patients who have received intralesional steroid injection in their buccal mucosa.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous Platelet rich plasma<br>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. | Other: Autologous Platelet rich plasma<br>* Intralesional injection of 1 milliliter of autologous Platelet rich plasma in the oral erosions every 2 weeks for 3 months.<br>* Other names: autologous PRP;|
| Active Comparator: Triamcinolone acetonide<br>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. | Drug: Triamcinolone Acetonide<br>* 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.<br>* Other names: Kenacort;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months | 
| Improvement of the depth of oral erosions. |  | 3 months | 
| Improvement of the degree of erythema of oral erosions. |  | 3 months |