Study Reference CLS001-CO-PR-006
Research type
Research Study
Full title
A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety of Omiganan Topical Gel in Subjects with Rosacea.
IRAS ID
187484
Contact name
Girish Gupta
Contact email
Sponsor organisation
Cutanea Life Sciences, Inc.
Eudract number
2015-002921-20
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.
Study Period (Planned):
Start -First participant enrolled: September 2015
End - Last participant last visit: September 2017
Phase of Development: Phase 3
Objectives: To evaluate the long-term safety of omiganan topical gel applied once daily to the face of participants with papulopustular rosacea
Methodology: Open-label, multi-centre, long-term safety study
Number of Participants (planned): Up to 300 enrolled, to achieve up to 300 evaluable at 6 months and up to 100 at 12 months
Number of Sites: Approximately 35 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 severe
papulopustular rosacea (Investigators Global Assessment (IGA) score of 4)
lnvestigational Product: Omiganan topical gel
Comparator Product: None
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: Up to 12 months (52 Weeks± 14 Days)REC name
West of Scotland REC 1
REC reference
15/WS/0220
Date of REC Opinion
16 Nov 2015
REC opinion
Further Information Favourable Opinion