Eligibility Details:
Inclusion Criteria:
- OLP patients with at least one visible and measurable symptomatic ulcerative OLP
lesion, assessable via OLP Clinician Reported Outcome Measure (OLPClinROM).
- 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: Corticosteroids,
Antibiotics, Retinoids, Immunosuppressive drugs (e.g. azathioprine, cyclosporine,
mycophenolate mofetil, or biologics), Antimycotics.
- Any of the following topical treatments used in the oral cavity prior to baseline
visit: Corticosteroids, Antibiotics, Cyclosporine, Tacrolimus, Pimecrolimus,
Antimycotics, Retinoids.
- 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.
- Patients who previously have failed to respond to OLP treatments with systemic
glucocorticosteroids, methotrexate, cyclosporine, retinoids and/or azathioprine.
- 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. 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.
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-yes
