Comparison Between Injections of Steroids and Autologous Platelet Rich Plasma in the Oral Erosions of Pemphigus Vulgaris
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|ClinicalTrials.gov Identifier: NCT02828163|
Recruitment Status : Completed
First Posted : July 11, 2016
Last Update Posted : March 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Oral Pemphigus Vulgaris||Other: Autologous Platelet rich plasma Drug: Triamcinolone Acetonide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Comparative Study Between Intralesional Autologous Platelet Rich Plasma and Intralesional Triamcinolone Acetonide in the Oral Erosions of Pemphigus Vulgaris Patients|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
Experimental: 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.
Other: Autologous Platelet rich plasma
Intralesional injection of 1 milliliter of autologous Platelet rich plasma in the oral erosions every 2 weeks for 3 months.
Other Name: autologous PRP
Active Comparator: 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.
Drug: Triamcinolone Acetonide
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 Name: Kenacort
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02828163
|Faculty of Medicine Cairo University Dermatology Department|
|Cairo, Please Select, Egypt, 11956|
|Study Chair:||Mohamed HM EL-Komy, M.D||Dermatology Department Cairo University|