Omiganan CLS001 Dose Finding Trials

Written by on February 7, 2013 in clinical trials, New Rosacea Treatments with 0 Comments

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A just-listed clinical trial shows that Cutanea Life Sciences are trialling Omiganan CLS001 to find the best dose when treating the papules and pustules of rosacea.

The 240 trialists will be assessed over 12 weeks to see if there is a reduction in lesions. Patients with at least rosacea lesions are to included in the trial.

We learnt early last year that Osaka, Japan based Maruho acquired Cutanea Life Sciences.

Further reinforcing the glacial pace of new drug development, we first learnt in 2006 that Cutanea were trialing Omiganan for rosacea.

From Cutanea Life Sciences files IPO to fund Omiganan development

CLS001 (omiganan pentahydrochloride) is described as “a novel cationic antimicrobial peptide in development for the treatment of inflammatory papules and pustules associated with rosacea”.

Further; “CLS001 is formulated in an aqueous based topical gel.  It is designed to provide cosmetic elegance with minimal irritation.  Cutanea believes that CLS001 will offer the following advantages: rapid onset of action, antimicrobial and anti-inflammatory activity, and non-detectable systemic absorption, thereby causing minimal adverse side effects.”

Clinical Trial

Clinical Trial NCT01784133

A Twelve Week Safety and Efficacy Study in Rosacea

A Phase 2, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Three Once-Daily CLS001 Topical Gels Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea.

Sponsor: Cutanea Life Sciences, Inc.

Drug: omiganan, Phase 2

Estimated Enrollment: 240
Study Start Date: March 2013
Estimated Primary Completion Date: November 2013

Primary Outcome Measures:

  • Change in inflammatory lesion count

Secondary Outcome Measures:

  • Success on IGA defined as clear or almost clear

The purpose of this study is to evaluate the safety and efficacy of one-daily topical application of CLS001 low, mid and high dose compared to vehicle gel in subjects with papulopustular rosacea.

Arms: omiganan low dose, omiganan mid dose, omiganan high dose, Vehicle group

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About the Author

About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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