Study Reference CLS001-CO-PR-004

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects with Papulopustular Rosacea with an Open-Label Safety Extension

• IRAS ID

  187482

• Contact name

  Girish Gupta

• Contact email

  Girish.Gupta@lanarkshire.scot.nhs.uk

• Sponsor organisation

  Cutanea Life Sciences, Inc.

• Eudract number

  2015-002919-15

• Duration of Study in the UK

  1 years, 10 months, 0 days

• Research summary

  The purpose of this study is to evaluate an investigational drug, Omiganan topical gel, sponsored by Cutanea Life Sciences, Inc. Cutanea Life Sciences is developing Omiganan gel for the treatment of papulopustular rosacea. The exact cause of rosacea is unknown and may be in due in part to an inflammatory process. Recent research has shown that Omiganan may have anti-inflammatory properties and may therefore help prevent the signs and symptoms of rosacea. This study is experimental. This means Omiganan gel has not been approved by the Regulatory
  Authorities for medical use in people. The study will assess if the study gel is safe, and how the study gel affects the rosacea on a participants face.
  Study Period (Planned):
  Start -First participant enrolled: September 2015
  End - Last participant last visit: September 2017
  Phase of Development: Phase 3
  Objective: To evaluate the safety and effectiveness of once daily application of omiganan topical gel compared to vehicle (placebo) topical gel in participants with papulopustular rosacea.
  Methodology: Double-blind, multicentre, randomised, placebo-controlled, parallel comparison with an open label extension.
  Number of Participants: 450 (225 per treatment group)
  Number of Sites: Approximately 50 sites in the United States, Canada, Germany, France, Netherlands, United Kingdom, Ireland, Sweden, Australia and New Zealand.
  Diagnosis and Main Criteria for Inclusion: Male or non-pregnant female participants at least 18 years of age with papulopustular rosacea, including at least 30 inflammatory lesions, and an
  Investigators Global Assessment (IGA) grade 4 (severe) at baseline.
  lnvestigational Product: Omiganan topical gel
  Comparator Product: Vehicle (placebo) gel
  Dose: Apply once daily as a thin film, to the entire face
  Mode of Administration: Topical application to the entire face avoiding contact with the mouth, eyes and inside the nose.
  Duration of Treatment: 12 weeks in the double blind phase, followed by up to 40 weeks open label
  

• REC name

  West of Scotland REC 1

• REC reference

  15/WS/0219

• Date of REC Opinion

  16 Nov 2015

• REC opinion

  Further Information Favourable Opinion