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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
Sponsor:
Information provided by (Responsible Party):
Marwah Adly Saleh, Cairo University

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

Condition or disease Intervention/treatment Phase
Oral Pemphigus Vulgaris Other: Autologous Platelet rich plasma Drug: Triamcinolone Acetonide Phase 3

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 Three milliliters of blood will be withdrawn from each patient.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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. Improvement of the depth of oral erosions. [ Time Frame: 3 months ]
  3. Improvement of the degree of erythema of oral erosions. [ Time Frame: 3 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Egypt
Faculty of Medicine Cairo University Dermatology Department
Cairo, Please Select, Egypt, 11956
Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Mohamed HM EL-Komy, M.D Dermatology Department Cairo University

Publications:
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Responsible Party: Marwah Adly Saleh, Assistant Professor, Cairo University
ClinicalTrials.gov Identifier: NCT02828163     History of Changes
Other Study ID Numbers: PRP # steroids in pemphigus
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Pemphigus
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action