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Intra-oral Treatment of OLP With Rivelin®-CLO Patches

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03592342
Recruitment Status : Completed
First Posted : July 19, 2018
Last Update Posted : July 14, 2020
Sponsor:
Collaborators:
Proinnovera GmbH
X-act Cologne Clinical Research GmbH
Information provided by (Responsible Party):
Dermtreat

Tracking Information
First Submitted Date  ICMJE June 19, 2018
First Posted Date  ICMJE July 19, 2018
Last Update Posted Date July 14, 2020
Actual Study Start Date  ICMJE June 28, 2018
Actual Primary Completion Date December 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2018)
Change in ulcer area [ Time Frame: 4 weeks ]
The change will be calculated from baseline to end of trial
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2018)
  • Change in lesion area [ Time Frame: 4 weeks ]
    The change will be calculated from baseline to end of trial
  • Change in 5-point erythema score [ Time Frame: 4 weeks ]
    The change will be calculated from baseline to end of trial using a 5-point erythema score (assessed as no redness (0) or very severe redness (4))
  • Change in Clinical global impression score [ Time Frame: 4 weeks ]
    The change will be calculated from baseline to end of trial using the Clinical Global Impression Score assessed on a 5-point rating scale ranging between no disease (0) and very severe disease (4)
  • Change in OLPSSM total score (item #1 to #7) [ Time Frame: 4 weeks ]
    The change will be calculated from baseline to end of trial. The OLPSSM (OLP Symptom Severity Measure) is a recently developed questionnaire, which serves for the patient to assess his/her specific OLP symptoms. This questionnaire consists of overall 12 items, to be assessed at different time points. Most items should be completed on a daily basis (in the evening). These items will be assessed as part of the patient's eDiary
  • Change in individual diary symptom scores (item #1 to #7 of the OLPSSM) [ Time Frame: 4 weeks ]
    The change will be calculated from baseline to end of trial. The OLPSSM (OLP Symptom Severity Measure) is a recently developed questionnaire, which serves for the patient to assess his/her specific OLP symptoms. This questionnaire consists of overall 12 items, to be assessed at different time points. Most items should be completed on a daily basis (in the evening). These items will be assessed as part of the patient's eDiary.
  • Change in worst symptoms at anatomical sites [ Time Frame: 4 weeks ]
    The change will be calculated from baseline to end of trial
  • The proportion of positive outcomes (score 0 or 1) on each of the 11 questions in the Patch Sensation Questionnaire [ Time Frame: 2 weeks ]
    The patient will assess the sensation of wearing the Rivelin® patches by answering 11 questions (the Patch sensation questionnaire) according to 5-point rating scales (ranging between 0 [most positive response] and 4 [most negative response]).The Patch Sensation Questionnaire will be completed during the clinic visit at baseline (visit 2) after first patch application and at visit 4 (2 weeks).
  • The proportion of patients with successful (>=80% of days on treatment) patch applications [ Time Frame: 4 weeks ]
    Defined as an adhesion time more than 30 minutes during the 4 weeks treatment
  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 4 weeks ]
    Frequency and intensity of adverse events (AEs) reported during the study
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intra-oral Treatment of OLP With Rivelin®-CLO Patches
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Parallel Group Clinical Study to Assess the Safety and Efficacy of Three Doses of Clobetasol Propionate When Administered Intra-orally Twice Daily in Patients With Oral Lichen Planus (OLP) Using Rivelin®-CLO Patches
Brief Summary Participants with symptomatic Oral Lichen Planus lesions will be treated with Rivelin® patches containing either 0, 1, 5, or 20 μg clobetasol per patch. Each participant will apply up to 6 patches twice daily for 4 weeks.
Detailed Description

Randomized, double-blind, placebo-controlled, parallel group clinical study with 3 active dose arms (Rivelin®-CLO patches) and one placebo arm (Rivelin® plain patch). Up to 6 Rivelin® patches will be applied to symptomatic ulcerative and symptomatic erythematous OLP lesions.

After screening (visit 1, day -14 to day -7), patients who have signed the informed consent form and who are fulfilling the inclusion criteria and none of the exclusion criteria will be randomized at baseline (visit 2, day 1) to one of the four treatment arms in a double-blinded fashion.

  • Arm A: Rivelin® plain patch (Placebo)
  • Arm B: Rivelin®-CLO 1 μg/patch
  • Arm C: Rivelin®-CLO 5 μg/patch
  • Arm D: Rivelin®-CLO 20 μg/patch Randomization will be 1:1:1:1 and patients will be stratified according to number of patches needed (1-3 and 4-6).

The screening phase ranges between 7 and 14 days, i.e. that the screening visit (visit 1) needs to be performed 7 days prior to baseline at latest. For visits 3 (day 8), 4 (day 15), 5 (day 22), and 6 (day 29) a visit window of +/- 2 days will be allowed. Visit 7 will be defined as visit 6 + 14 days, with a visit window of +/- 3 days.

Randomized patients will enter a 28-days (4-weeks) treatment period. Dosing is two times per day (morning and evening) with patches applied directly on OLP lesions as instructed by a clinician or delegated site staff. Patients will record symptoms and adhesion time in daily diaries by using an electronic diary (eDiary).

During the treatment period, the treating physician or dentist will perform an assessment of the disease status on a weekly basis. A final examination of disease status will be performed at the follow-up visit (visit 7), 14 days after the end of treatment.

Other treatments of symptomatic OLP lesions during the study are prohibited. Only rescue analgesics determined by the investigator at study entry on a patient specific basis are allowed to be taken, in case that OLP associated symptoms like pain cannot be managed by the sole use of the patches. All doses of rescue analgesics will be recorded by the patient in the eDiary.

If the patients' condition is worsening (at the discretion of the investigator) and if associated symptoms cannot longer be managed acceptably by the additional use of rescue analgesics, i.e. if there is the need to start any other OLP treatment, IMP treatment for that patient should be discontinued prematurely and patient should be withdrawn from the study.

At visit 3 (day 8), a blood sample will be drawn to measure the blood plasma concentration of clobetasol and to determine the morning serum cortisol level (between 7 and 9 AM).

All patients will have a follow-up visit that will be performed 2 weeks after the EoT/ET visit (visit 6).

Safety data (by means of AE documentation including fungal infections and SAE reporting) will be closely monitored by an independent Data and Safety Monitoring Board (DSMB). DSMB will advise the Sponsor of any potential risk for the safeguard of patients.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomization will be 1:1:1:1 to 1 of the 4 parallel arms (3 active and 1 placebo) and patients will be stratified according to number of patches needed (1-3 and 4-6).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
All 4 interventions will be similar in appearance and be allocated by use of a blinded kit number (each kit contains drug for 1 week).
Primary Purpose: Treatment
Condition  ICMJE Oral Lichen Planus
Intervention  ICMJE Drug: Clobetasol Propionate
Rivelin® patch is a two-layer patch comprised of a muco-adhesive, drug-delivery layer and a protective layer.
Study Arms  ICMJE
  • Placebo Comparator: Rivelin® plain patches
    Dosing is two times per day (morning and evening) with Rivelin® plain patches (placebo).
    Intervention: Drug: Clobetasol Propionate
  • Experimental: Rivelin®-CLO patch 1µg
    Dosing is two times per day (morning and evening) with Rivelin®-CLO patch 1µg Clobetasol propionate per patch.
    Intervention: Drug: Clobetasol Propionate
  • Experimental: Rivelin®-CLO patch 5µg
    Dosing is two times per day (morning and evening) with Rivelin®-CLO patch 5µg Clobetasol propionate per patch.
    Intervention: Drug: Clobetasol Propionate
  • Experimental: Rivelin®-CLO patch 20µg
    Dosing is two times per day (morning and evening) with Rivelin®-CLO patch 20µg Clobetasol propionate per patch.
    Intervention: Drug: Clobetasol Propionate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2020)
140
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2018)
240
Actual Study Completion Date  ICMJE December 20, 2019
Actual Primary Completion Date December 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Denmark,   Germany,   Ireland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03592342
Other Study ID Numbers  ICMJE DT-001-R-004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Dermtreat
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Dermtreat
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Proinnovera GmbH
  • X-act Cologne Clinical Research GmbH
Investigators  ICMJE
Study Chair: Lars Siim Madsen, PhD Dermtreat
Principal Investigator: Michael Brennan, DDS Carolinas Healthcare System, Dept. of Oral Medicine
PRS Account Dermtreat
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP