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

Phase 3

Completed

• Conditions: Oral Pemphigus Vulgaris
• Interventions: Other: Autologous Platelet rich plasma; Drug: Triamcinolone Acetonide

• Registration Number: NCT02828163
• Lead Sponsor: Cairo University

Brief Summary

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 Three milliliters of blood will be withdrawn from each patient.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 Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-07-06
• Study First Posted: 2016-07-11
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autologous Platelet rich plasma	Autologous Platelet rich plasma	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.
Triamcinolone acetonide	Triamcinolone Acetonide	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.

Primary Outcome Measures

Name	Time	Method
Improvement of the size of oral erosions.	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.	3 months
Improvement of the degree of erythema of oral erosions.	3 months

Trial Locations

Locations (1)

Faculty of Medicine Cairo University Dermatology Department; 🇪🇬 Cairo, Please Select, Egypt