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

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Oral Pemphigus Vulgaris

Treatments: Drug: Triamcinolone Acetonide; Other: Autologous Platelet rich plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT02828163

PRP # steroids in pemphigus

Details and patient eligibility

About

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

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 Three milliliters of blood will be withdrawn from each patient.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

Enrollment: 11 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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11 participants in 2 patient groups

Autologous Platelet rich plasma

Experimental group

Description:

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.

Treatment:

Other: Autologous Platelet rich plasma

Triamcinolone acetonide

Active Comparator group

Description:

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.

Treatment:

Drug: Triamcinolone Acetonide