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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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 Three milliliters of blood will be withdrawn from each patient.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.
Sponsor: Cairo University

Current 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Cairo University

Dates:
Date Received: June 27, 2016
Date Started: January 2016
Date Completion:
Last Updated: March 2, 2017
Last Verified: March 2017