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

Primary Purpose

Oral Pemphigus Vulgaris

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Autologous Platelet rich plasma
Triamcinolone Acetonide
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Pemphigus Vulgaris

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Faculty of Medicine Cairo University Dermatology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Autologous Platelet rich plasma

Triamcinolone acetonide

Arm 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.

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.

Outcomes

Primary Outcome Measures

Improvement of the size of oral erosions.
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.
Improvement of the degree of erythema of oral erosions.

Secondary Outcome Measures

Full Information

First Posted
June 27, 2016
Last Updated
March 2, 2017
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT02828163
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Pemphigus Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous Platelet rich plasma
Arm Type
Experimental
Arm 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.
Arm Title
Triamcinolone acetonide
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Autologous Platelet rich plasma
Other Intervention Name(s)
autologous PRP
Intervention Description
Intralesional injection of 1 milliliter of autologous Platelet rich plasma in the oral erosions every 2 weeks for 3 months.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Other Intervention Name(s)
Kenacort
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement of the size of oral erosions.
Description
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
Time Frame
3 months
Title
Improvement of the depth of oral erosions.
Time Frame
3 months
Title
Improvement of the degree of erythema of oral erosions.
Time Frame
3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed HM EL-Komy, M.D
Organizational Affiliation
Dermatology Department Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Medicine Cairo University Dermatology Department
City
Cairo
State/Province
Please Select
ZIP/Postal Code
11956
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26340377
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.
Results Reference
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PubMed Identifier
25558949
Citation
Saleh MA. Pemphigus in the Arab world. J Dermatol. 2015 Jan;42(1):27-30. doi: 10.1111/1346-8138.12676.
Results Reference
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PubMed Identifier
20236381
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.
Results Reference
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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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