Clinical trial NCT02828163: Comparison Between Injections of Steroids and Autologous Platelet Rich Plasma in the Oral Erosions of Pemphigus Vulgaris
Official title: Comparative Study Between Intralesional Autologous Platelet Rich Plasma and Intralesional Triamcinolone Acetonide in the Oral Erosions of Pemphigus Vulgaris Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Oral Pemphigus Vulgaris
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Three milliliters of blood will be withdrawn from each patient.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

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement of the size of oral erosions.
timeFrame: 3 months
measure: Improvement of the depth of oral erosions.
timeFrame: 3 months
measure: Improvement of the degree of erythema of oral erosions.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Cairo University Dermatology Department
state: Please Select
Study officials:
affiliation: Dermatology Department Cairo University
name: Mohamed HM EL-Komy, M.D
role: STUDY_CHAIR
References:
citation: EL-Komy MH, Hassan AS, Abdel Raheem HM, Doss SS, EL-Kaliouby M, Saleh NA, Saleh MA. Platelet-rich plasma for resistant oral erosions of pemphigus vulgaris: A pilot study. Wound Repair Regen. 2015 Nov-Dec;23(6):953-5. doi: 10.1111/wrr.12363. Epub 2015 Nov 4.
citation: Saleh MA. Pemphigus in the Arab world. J Dermatol. 2015 Jan;42(1):27-30. doi: 10.1111/1346-8138.12676.
citation: Mignogna MD, Fortuna G, Leuci S, Adamo D, Dell'Aversana Orabona G, Ruoppo E. Adjuvant triamcinolone acetonide injections in oro-pharyngeal pemphigus vulgaris. J Eur Acad Dermatol Venereol. 2010 Oct;24(10):1157-65. doi: 10.1111/j.1468-3083.2010.03610.x.