NCT02828163

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

9 months

First QC Date

June 27, 2016

Last Update Submit

March 2, 2017

Conditions

Oral Pemphigus Vulgaris

Outcome Measures

Primary Outcomes (3)

  • 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

    3 months

  • Improvement of the depth of oral erosions.

    3 months

  • Improvement of the degree of erythema of oral erosions.

    3 months

Study Arms (2)

Autologous Platelet rich plasma

EXPERIMENTAL

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

Triamcinolone acetonide

ACTIVE COMPARATOR

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

Interventions

Autologous Platelet rich plasmaOTHER

Intralesional injection of 1 milliliter of autologous Platelet rich plasma in the oral erosions every 2 weeks for 3 months.

Also known as: autologous PRP
Autologous Platelet rich plasma
Triamcinolone AcetonideDRUG

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.

Also known as: Kenacort
Triamcinolone acetonide

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pemphigus vulgaris patients having bilateral erosions in the buccal mucosa.

You may not qualify if:

  • Pemphigus vulgaris patients who do not have oral erosions.
  • Pemphigus vulgaris patients who have received intralesional steroid injection in their buccal mucosa.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Cairo University Dermatology Department

Cairo, Please Select, 11956, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 26340377BACKGROUND

  • Saleh MA. Pemphigus in the Arab world. J Dermatol. 2015 Jan;42(1):27-30. doi: 10.1111/1346-8138.12676.

    PMID: 25558949BACKGROUND

  • 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.

    PMID: 20236381BACKGROUND

MeSH Terms

Interventions

Triamcinolone AcetonideTriamcinolone

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Mohamed HM EL-Komy, M.D

    Dermatology Department Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 27, 2016

First Posted

July 11, 2016

Study Start

January 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

March 3, 2017

Record last verified: 2017-03

Locations

EG(1)