Clinical trial: Intra-oral Treatment of OLP With Rivelin®-CLO Patches (NCT03592342)

Eligibility criteria:
Inclusion Criteria:

          -  OLP patients with at least one visible and measurable symptomatic ulcerative OLP
             lesion, assessable via OLP Clinician Reported Outcome Measure (OLPClinROM).

          -  Diagnosis of LP histologically confirmed by result of either an existing clinically
             relevant biopsi or a new clinically representative biopsy at first screening visit
             (i.e. a biopsy report either indicative of OLP, LP or indicative of lichenoid
             inflammation will be sufficient).

          -  Patients aged ≥ 18 years.

          -  Patients practicing daily oral hygiene (by tooth brushing and/or mouth rinse) and
             willing to maintain at least their routine oral hygiene procedure during study
             participation.

          -  Willingness to keep already used permitted concomitant medication, food supplements
             (e.g. probiotics) or herbals, which might have in the discretion of the investigator a
             potential influence on OLP, on a stable basis during the study.

        Exclusion Criteria:

          -  Patients requiring more than 6 patches (corresponding to an area of approximately 3
             cm2 per patch) to cover symptomatic ulcerative and erythematous OLP lesions at
             baseline visit.

          -  Ongoing active visible fungal, bacterial or viral infection of oral mucosa, including
             ongoing treatment of those at baseline.

          -  Patient with any un-healed oral surgery (including recent diagnostic biopsies, if
             applicable) or oral laser therapeutic wound(s) at baseline visit.

          -  Any of the following systemic treatments prior to baseline visit and throughout the
             study:

               -  Protease inhibitors used for the treatment of HIV (e.g. atazanavir, idinavir,
                  nelfinavir, etc.): 1 week

               -  Corticosteroids (i.v., intra articular, intra-lesional): 4 weeks

               -  Antimycotics: 4 weeks The following systemic treatments are allowed, if on stable
                  dose for a defined period of time to baseline and throughout the study.

               -  Antibiotics: 4 weeks

               -  Corticosteroids (oral, rectal, inhalative) washout/stable with maxinum dose of 10
                  mg daily prednisolone or equivalent for 4 weeks.

               -  Retinoids: 12 weeks

               -  Immunosuppressive drugs (e.g. azathioprine, cyclosporine, mycophenolate mofetil,
                  or biologics): 12 weeks

          -  Any of the following topical treatments used in the oral cavity prior to baseline
             visit:

               -  Corticosteroids: 2 weeks

               -  Antibiotics: 2 weeks

               -  Cyclosporine: 2 weeks

               -  Tacrolimus, pimecrolimus: 2 weeks

               -  Antimycotics: 2 weeks

               -  Retinoids: 4 weeks

          -  Phototherapy in oral cavity prior to baseline visit: UVB, PUVA.

          -  Current participation in another clinical study and/or having received treatment with
             any non-marketed / investigational medicinal product (drug substance or medical
             device) within 4 weeks prior to screening.

          -  Known or suspected intolerance/hypersensitivity/resistance to clobetasol propionate or
             any component of the investigational medicinal product.

          -  Any history of squamous cell carcinoma (even if resected), as well as history of other
             non-squamous cell carcinoma (e.g. sarcoma, salivary gland tumors) that have been
             managed with radiation or chemotherapy.

          -  History of cancer (except resected cutaneous basal cell carcinoma and except in situ
             cervical cancer) unless it can be documented that the patient has been in a
             disease-free state for at least 5 years, or at least 2 years in a disease-free state
             for low-grade cancers. In case of clinical suspicion of malignancy in the oral cavity,
             a patient can only be included after an excluding biopsy.

          -  Professional dental cleaning within 2 weeks prior to baseline and unwillingness to
             refrain from professional dental cleaning during study conduct.

          -  Close affiliation with the investigator (e.g. a close relative) or persons working at
             the study sites or patient who is an employee of the Sponsor's company.

          -  Pregnant, confirmed by a positive pregnancy test, or nursing (lactating) women, or
             women of childbearing potential (WOCP) planning to become pregnant or WOCP not using
             or willing to continue to use a defined highly effective method of contraception
             throughout the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers.  The rashes are mildly itchy. The patient has no other medical conditions and takes no medications.  Vital signs are normal.  On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer.  There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance.

Patient description (patient's own words): I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction.

Does the patient match the trial criteria? 0