NCT03293368

Efficacy of Intralesional Injection of Platelet Rich Plasma in the Treatment of Patients With Erosive Oral Lichen Planus

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Erosive Oral Lichen Planus

Interventions

Type	Name	Description
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.
DRUG	Triamcinolone Acetonide	0.5 ml of triamcinolone acetonide 40mg will be injected per 1 cm2 of eroded oral mucosa

Timeline

• Start date: 2018-01-01
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2017-09-26
• Last updated: 2023-02-09

Locations

1 site across 1 country: Egypt