Completed

NCT Number: NCT02828163

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

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

Completed

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Key information

Conditions

Oral Pemphigus Vulgaris

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Medicine Cairo University Dermatology Department

Cairo, Please Select, 11956, Egypt

About this study

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 Three milliliters of blood will be withdrawn from each patient.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous Platelet rich plasma

Other

Intralesional injection of 1 milliliter of autologous Platelet rich plasma in the oral erosions every 2 weeks for 3 months.

Other names: autologous PRP

Triamcinolone Acetonide

Drug

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.

Other names: Kenacort

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Jul 11, 2016
Registry last updated: Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.