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.
74 studies on the registry are indexed under Lichen Planus; 15 are open to participants now.
This study's enrollment of 20 is below the median of 30 across 55 interventional studies indexed under Lichen Planus.
Browse Lichen Planus studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Jan 2018 to primary completion in Jan 2021, 36 months.
Of 16 phase 2 interventional studies under Lichen Planus, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 28. This study's 36 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Platelet rich plasma