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Trial record 1 of 1 for:    NCT03592342
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Intra-oral Treatment of OLP With Rivelin®-CLO Patches

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ClinicalTrials.gov Identifier: NCT03592342
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : October 17, 2018
Sponsor:
Collaborators:
Proinnovera GmbH
X-act Cologne Research GmbH
Information provided by (Responsible Party):
Dermtreat

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.

Condition or disease Intervention/treatment Phase
Oral Lichen Planus Drug: Clobetasol Propionate Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
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
Official Title: 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
Actual Study Start Date : June 28, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Rivelin® plain patches
Dosing is two times per day (morning and evening) with Rivelin® plain patches (placebo).
Drug: Clobetasol Propionate
Rivelin® patch is a two-layer patch comprised of a muco-adhesive, drug-delivery layer and a protective layer.

Experimental: Rivelin®-CLO patch 1µg
Dosing is two times per day (morning and evening) with Rivelin®-CLO patch 1µg Clobetasol propionate per patch.
Drug: Clobetasol Propionate
Rivelin® patch is a two-layer patch comprised of a muco-adhesive, drug-delivery layer and a protective layer.

Experimental: Rivelin®-CLO patch 5µg
Dosing is two times per day (morning and evening) with Rivelin®-CLO patch 5µg Clobetasol propionate per patch.
Drug: Clobetasol Propionate
Rivelin® patch is a two-layer patch comprised of a muco-adhesive, drug-delivery layer and a protective layer.

Experimental: Rivelin®-CLO patch 20µg
Dosing is two times per day (morning and evening) with Rivelin®-CLO patch 20µg Clobetasol propionate per patch.
Drug: Clobetasol Propionate
Rivelin® patch is a two-layer patch comprised of a muco-adhesive, drug-delivery layer and a protective layer.




Primary Outcome Measures :
  1. Change in ulcer area [ Time Frame: 4 weeks ]
    The change will be calculated from baseline to end of trial


Secondary Outcome Measures :
  1. Change in lesion area [ Time Frame: 4 weeks ]
    The change will be calculated from baseline to end of trial

  2. 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))

  3. 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)

  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

  5. 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.

  6. Change in worst symptoms at anatomical sites [ Time Frame: 4 weeks ]
    The change will be calculated from baseline to end of trial

  7. 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).

  8. 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

  9. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 4 weeks ]
    Frequency and intensity of adverse events (AEs) reported during the study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592342


Contacts
Contact: Pia Jensen +4560256987 pj@dermtreat.com

Locations
United States, Massachusetts
Tufts University, School of Dental Medicine Recruiting
Boston, Massachusetts, United States, 02111
Contact: Athena Papas, DMD    617-636-3931    Athena.Papas@tufts.edu   
Brigham and Women's Hospital, Division of Oral Medicine and Dentistry Recruiting
Boston, Massachusetts, United States, 02115
Contact: Vidya Sankar, DMD, MHS    617-525-8412    vsankar@bwh.harvard.edu   
United States, New York
NYU College of Dentistry, Bluestone Center for Clinical Research Recruiting
New York, New York, United States, 10010
Contact: Alexander R Kerr, DDS, MSD    347-721-7506    ark3@nyu.edu   
United States, North Carolina
UNC Dermatology and Skin Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27516
Contact: Donna Aline Culton, MD    +1 984 974 3669    donna_culton@med.unc.edu   
Contact: Natasha Marvi, Study Coordinator    +1 984 974 3670    natasha_marvi@med.unc.edu   
Carolinas Center for Oral Health Recruiting
Charlotte, North Carolina, United States, 28209
Contact: Joul J Napenas, DDS    704-512-2110    joel.napenas@atriumhealth.org   
Wake Forest University, Health Sciences Dept. of Dermatology Recruiting
Winston-Salem, North Carolina, United States, 27104
Contact: William Huang, MD, MPH    336-716-3775    whuang@wakehealth.edu   
United States, Pennsylvania
University of Pennsylvania Health System, Dept. Oral amd Maxillofacial Surgery Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Thomas P Sollecito, DMD    215-898-6627    tps@upenn.edu   
United States, Texas
Texas A&M University (TAMU), College of Dentistry Not yet recruiting
Dallas, Texas, United States, 75246
Contact: Paras B Patel, DDS    214-828-8116    ppatel10@tamhsc.edu   
UT Southwestern Medical Center Department of Surgery Not yet recruiting
Dallas, Texas, United States, 75390-9109
Contact: Thomas Schlieve, DDS, MD    214-648-3034    Thomas.Schlieve@UTSouthwestern.edu   
Canada, Alberta
Kaye Edmonton Clinic Not yet recruiting
Edmonton, Alberta, Canada, T6G1Z1
Contact: Tim McGraw, D.D.S    +1-780 492-5195    wmcgaw@ualberta.ca   
Contact: Breanne Stewart, Coordinator    +1-780-974-8606    breanne1@ualberta.ca   
Canada, Ontario
Health Sciences North, North East Cancer Center Recruiting
Sudbury, Ontario, Canada, P3E5JL
Contact: Debbie Saunders, D.D.S    +1-705 523-7334    dsaunders@hsnsudbury.ca   
Contact: Pamela Leduc, Coordinator    +1-705-523-7300 ext 1923      
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Morten Schiødt, DDS, Dr    +45 3545 1880    morten.schioedt@regionh.dk   
Germany
Universitätsklinikum Bonn (AöR), Klinik und Poliklinik für Dermatologie und Allergologie Recruiting
Bonn, Germany, 53127
Contact: Thomas Bieber, Prof Dr Med    +49 (0)228 287 16811    Thomas.Bieber@ukb.uni-bonn.de   
LMU München, Klinik und Poliklinik für Dermatologie und Allergologie Recruiting
Munich, Germany, 80337
Contact: Thomas Ruzicka, Prof Dr Med    +49 (0)89 44005 60051    Thomas.Ruzicka@med.uni-muenchen.de   
Ireland
Cork University Dental School and Hospital Not yet recruiting
Cork, Ireland, T12 E8YV
Contact: Christine McCreary, Dr    +353 (0)21 4901105    C.McCreary@ucc.ie   
Dublin Dental University and Hospital Trinity College Dublin Not yet recruiting
Dublin, Ireland, D02 F589
Contact: Claire Healy, Dr    + 353 1 612 7314    claire.healy@dental.tcd.ie   
United Kingdom
Leeds Dental Institute Not yet recruiting
Leeds, United Kingdom, LS9 9LU
Contact: Alan Mighell, Dr    +44 (0)113 343 6121    A.J.Mighell@leeds.ac.uk   
King´s College London Dental Institute, Oral Clinical Research Unit Recruiting
London, United Kingdom, SE1 9RT
Contact: Richard Cook, Dr    +44 (0)20 78485958    richard_james.cook@kcl.ac.uk   
University College London and University College London Hospitals Trust Recruiting
London, United Kingdom, WC1X 8LD
Contact: Stefano Fedele, Dr    +44 (0)20 3456 1004    s.fedele@ucl.ac.uk   
University of Sheffield, School of Clinical Dentistry Recruiting
Sheffield, United Kingdom, S10 2TA
Contact: Anne Hegarty, Dr    +44 (0)114 2268669    anne.hegarty@sth.nhs.uk   
Sponsors and Collaborators
Dermtreat
Proinnovera GmbH
X-act Cologne Research GmbH
Investigators
Study Chair: Jens Hansen Dermtreat
Principal Investigator: Michael Brennan, DDS Carolinas Healthcare System, Dept. of Oral Medicine

Responsible Party: Dermtreat
ClinicalTrials.gov Identifier: NCT03592342     History of Changes
Other Study ID Numbers: DT-001-R-004
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dermtreat:
Patch
Rivelin-Clo Patch
Oral Lichen Planus
Ulcerative
Erythematous
OLP
OLPClinROM
OLPSSM

Additional relevant MeSH terms:
Lichen Planus
Lichen Planus, Oral
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Clobetasol
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs