NCT03293368

Brief Summary

After signing the informed consent, the participant will be allocated to either intervention or control group, then each participant in the intervention group will receive intralesional injections of platelet rich plasma extracted from their own blood in each visit as following:

  1. 1.12 ml of blood will be assembled from the veins of antecubital fossa
  2. 2.PRP preparation will be done according to Mostafa et al., 2013
  3. 3.0.5 ml of PRP will be injected per 1 cm2 of ulcerated mucosa

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2018

Typical duration for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

3 years

First QC Date

September 19, 2017

Last Update Submit

February 7, 2023

Conditions

Erosive Oral Lichen Planus

Keywords

OralLichen planusPRP

Outcome Measures

Primary Outcomes (1)

  • Reported Pain

    Pain and burning sensation assessed using Numerical rating scale

    3 months

Secondary Outcomes (2)

  • Clinical score

    3 months

  • Remission time

    3 months

Study Arms (2)

Platelet rich plasma

EXPERIMENTAL

0.5 ml of autologous platelet rich plasma prepared using a double spin technique described by Mostafa et al., 2013 will be injected in the center of eroded oral mucosa in patients suffering from oral lichen planus.

Biological: Platelet rich plasma

Croticosteroids

ACTIVE COMPARATOR

0.5 ml of triamcinolone acetonide 40 mg will be injected in the center of eroded oral mucosa in patients suffering from oral lichen planus.

Drug: Triamcinolone Acetonide

Interventions

Platelet rich plasmaBIOLOGICAL

Platelet rich plasma will be prepared from the patients own blood in the same visit using a double spin technique, then 0.5 ml of PRP will be injected per 1 cm2 of eroded oral mucosa.

Also known as: Platelet rich in growth factors
Platelet rich plasma
Triamcinolone AcetonideDRUG

0.5 ml of triamcinolone acetonide 40mg will be injected per 1 cm2 of eroded oral mucosa

Also known as: Corticosteroids, Steroids
Croticosteroids

Eligibility Criteria

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

You may qualify if:

  • Patients presenting with a clinical picture that assumes the diagnosis of erosive oral lichen planus (bilateral, more or less symmetrical erosive lesions with lacelike network of slightly raised gray white lesions (reticular pattern), and a histological findings that confirms the diagnosis (liquefaction degeneration of the basal cell layer with irregular-saw teeth like rete pegs.

You may not qualify if:

  • Systemic disorders such as hematological diseases, severe cardiovascular diseases, treatment with any drugs that could cause Lichenoid reaction.
  • Pregnancy or active breastfeeding
  • Patients who had lesion/lesions with dysplasia
  • Patients who received topical treatment for Oral Lichen planus in the last 2 weeks (Lee et al., 2013) or systemic treatment for OLP in the past 3 months.
  • Platelet count \< 150,000/mm3; Hgb \< 11 g/dl.
  • Immunosuppressed patients
  • Patients receiving therapy with anticoagulants and use of non-steroidal anti-inflammatory drugs in the 5 days before taking the blood sample.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, Egypt

Location

Related Publications (1)

  • Hijazi A, Ahmed W, Gaafar S. Efficacy of intralesional injections of platelet-rich plasma in patients with oral lichen planus: A pilot randomized clinical trial. Clin Exp Dent Res. 2022 Jun;8(3):707-714. doi: 10.1002/cre2.550. Epub 2022 Feb 26.

    PMID: 35218680DERIVED

MeSH Terms

Conditions

Lichen Planus

Interventions

Intercellular Signaling Peptides and ProteinsTriamcinolone AcetonideAdrenal Cortex HormonesSteroids

Condition Hierarchy (Ancestors)

Lichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsTriamcinolonePregnadienesPregnanesFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Soheir Gaafar, Professor

    Professor of oral medicine, diagnosis and periodontology. Faculty of Dentistry. Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

September 19, 2017

First Posted

September 26, 2017

Study Start

January 1, 2018

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

February 9, 2023

Record last verified: 2023-02

Locations

EG(1)