DT-001-R-004

• Research type

  Research Study

• Full 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

• IRAS ID

  239494

• Contact name

  Richard Cook

• Contact email

  richard_james.cook@kcl.ac.uk

• Sponsor organisation

  Dermtreat ApS

• Eudract number

  2017-002193-40

• Duration of Study in the UK

  0 years, 8 months, 1 days

• Research summary

  In this randomised, double-blind, placebo controlled, parallel group study, the efficacy and safety of Clobetasol Propionate will be investigated when administered as Rivelin®-CLO Patches intra-orally in patients with Oral Lichen Planus (OLP).
  240 adult patients clinically diagnosed with OLP will be enrolled.

  Oral Lichen Planus is an an oral inflammatory/infectious disease with associated lesions. Patients with inflammatory OLP have a demanding medical need because of severe pain and lower quality of life and propensity for depressions.

  To meet the medical need of OLP patients, the Sponsor has developed a mucosal adhesive patch technology coated with Clobetasol Propionate to be applied for relief of complications related to inflammatory, atrophic and/or ulcerative lesions in the oral cavity.
  Therewith, the medication will be directly placed on the position where the pain occurs.

  The highly potent corticosteroid Clobetasol propionate is effective for topical treatment of various skin disorders, thus making it an ideal combination agent with the Rivelin® patch for the treatment of OLP. Rivelin® plain patch will be used as reference product (placebo) to rule out any study effect on the lesions.

  In this study participation of the patient will last up to 8 weeks and the study will be conducted at 4 sites in the UK, 2 sites in Germany, 2 sites in Ireland, 1 site in Denmark and 9 sites in the US.
  This trial serves to show the efficacy of the product by change in ulcer area and to show the optimal dose for treatment.

• REC name

  London - Central Research Ethics Committee

• REC reference

  18/LO/0144

• Date of REC Opinion

  15 May 2018

• REC opinion

  Further Information Favourable Opinion