Study Reference CLS001-CO-PR-005
Research type
Research Study
Full title
A Phase 3, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects with Papulopustular Rosacea with a 4 Week Follow-up Period
IRAS ID
187483
Contact name
Anthony Bewley
Contact email
Sponsor organisation
Cutanea Life Sciences, Inc.
Eudract number
2015-002920-23
Duration of Study in the UK
1 years, 2 months, 29 days
Research summary
Rosacea is a chronic dermatologic disorder that primarily affects the facial skin. An estimated 16 million Americans have rosacea. The prevalence of rosacea in Europe is between 1% and 10% of the adult population. The clinical signs and symptoms of rosacea are: facial flushing, telangiectasia, facial erythema, central facial inflammatory papules and pustules, hypertrophy of the sebaceous glands of the nose and ocular changes. Rosacea has been classified into four different subtypes:
• Subtype 1: erythematotelangiectatic,
• Subtype 2: papulopustular,
• Subtype 3: phymatous and
• Subtype 4: ocular.
Each subtype has severity grades ranging from mild to severe. The subtypes may share common symptoms and may clinically overlap.
There is no cure for rosacea and treatment is aimed at alleviating the symptoms. Topical or oral medications are generally prescribed for mild to moderate papulopustular rosacea. Oral medications are typically prescribed for severe disease.Cutanea Life Sciences is developing omiganan topical 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 cationic peptides such as omiganan may have anti-inflammatory properties and may play a role in inhibiting the inflammatory response. Omiganan may also prevent the inflammatory cascade that is theorised to lead to the signs and symptoms of rosacea. A possible anti-inflammatory activity of omiganan is suggested by the observation of a reduction in inflammatory acne lesion counts with omiganan in two Phase 2 clinical trials.
This clinical trial will further evaluate the safety and efficacy of omiganan topical gel 1.75% w/w versus vehicle gel administered once daily over a 12-week treatment period in addition to providing long term safety data for subjects receiving treatment up to one year.
Topical Omiganan has the potential to become an important addition to the dermatologist’s armamentarium in treating severe rosacea.REC name
London - Bloomsbury Research Ethics Committee
REC reference
15/LO/1829
Date of REC Opinion
18 Dec 2015
REC opinion
Further Information Favourable Opinion