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Trial record 1 of 1 for:    Platelet Rich Plasma in the Treatment of Patients With Erosive Oral Lichen Planus
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Efficacy of Intralesional Injection of Platelet Rich Plasma in the Treatment of Patients With Erosive Oral Lichen Planus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03293368
Recruitment Status : Unknown
Verified September 2017 by Abdelhameed Hamid Mohammad Hijazi, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : September 26, 2017
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):
Abdelhameed Hamid Mohammad Hijazi, Cairo University

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. 12 ml of blood will be assembled from the veins of antecubital fossa
  2. PRP preparation will be done according to Mostafa et al., 2013
  3. 0.5 ml of PRP will be injected per 1 cm2 of ulcerated mucosa

The second group will receive triamcinolone acetonide 40 mg injected 1 ml per 1 cm2 of ulcerated mucosa

Both groups will receive a total of 4 injection, the injections will be carried out once a week.

Pain, lesions size and remission time are the outcomes will be assessed using a numerical rating scale (Seymour, 1982), clinical score according to Thongprasom et al., 1992 and binary scale for remission time according to Conrotto et al., 2006, respectively.

Assessment of the outcomes will be carried before the trial (baseline records) and before receiving the treatment in each visit by the primary investigator (H.A.) and the blinded assessor (Dr. A.W.) separately.

Each participant will have a total of 11 visits during the trial, 5 visits will be once every week during the trial and every 2 weeks for 3 months treatment free.


Condition or disease Intervention/treatment Phase
Erosive Oral Lichen Planus Biological: Platelet rich plasma Drug: Triamcinolone Acetonide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Intralesional Injection of Autologous Platelet Rich Plasma Versus Intralesional Injection of Corticosteroids on Pain Relief and Ulcers Healing in Patients With Erosive Oral Lichen Planus; Randomized Clinical Trial
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Platelet rich plasma
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
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.
Other Name: Platelet rich in growth factors

Active Comparator: Croticosteroids
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
0.5 ml of triamcinolone acetonide 40mg will be injected per 1 cm2 of eroded oral mucosa
Other Name: Corticosteroids, Steroids




Primary Outcome Measures :
  1. Pain [ Time Frame: 3 months ]
    Pain and burning sensation assessed using Numerical rating scale


Secondary Outcome Measures :
  1. Clinical score [ Time Frame: 3 months ]
    Clinical score using a 5 grades scoring system described by Thongprasom et al.,1992

  2. Remission time [ Time Frame: 3 months ]
    Time until flare up of the disease occur using a binary scale (Stable/Not stable) described by Conrotto et al., 2006



Information from the National Library of Medicine

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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): NCT03293368


Contacts
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Contact: AbdelHameed H. Hijazi, PhD +201026276333 abdelhameed.hijazi@dentistry.cu.edu.eg

Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Soheir Gaafar, Professor Professor of oral medicine, diagnosis and periodontology. Faculty of Dentistry. Cairo University
  Study Documents (Full-Text)

Documents provided by Abdelhameed Hamid Mohammad Hijazi, Cairo University:
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Responsible Party: Abdelhameed Hamid Mohammad Hijazi, PhD Student, Cairo University
ClinicalTrials.gov Identifier: NCT03293368    
Other Study ID Numbers: PRP-olp
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abdelhameed Hamid Mohammad Hijazi, Cairo University:
Oral
Lichen planus
PRP
Additional relevant MeSH terms:
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Lichen Planus, Oral
Lichen Planus
Mouth Diseases
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Stomatognathic 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