A Phase 2 interventional study of Platelet rich plasma and Triamcinolone Acetonide in Erosive Oral Lichen Planus, sponsored by Cairo University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2023-02-09.
Sponsored by Cairo University · Phase 2, Interventional, and Treatment
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:
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.
Exclusion Criteria:
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
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
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
0.5 ml of triamcinolone acetonide 40mg will be injected per 1 cm2 of eroded oral mucosa
Also known as: Corticosteroids, Steroids
Reported Pain
Pain and burning sensation assessed using Numerical rating scale
Time frame: 3 months
Clinical score
Clinical score using a 5 grades scoring system described by Thongprasom et al.,1992
Time frame: 3 months
Remission time
Time until flare up of the disease occur using a binary scale (Stable/Not stable) described by Conrotto et al., 2006
Time frame: 3 months
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Cairo University