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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01784133

Enrollment

240

Registered

2013-02-05

Start date

2013-03-31

Completion date

Unknown

Last updated

2015-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Papulopustular Rosacea

Keywords

rosacea

Brief summary

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

Interventions

DRUGomiganan

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* diagnosis of papulopustular rosacea (at least 15 lesions)

Exclusion criteria

* nodular rosacea or subtype 3 * clinically significant abnormal findings that would interfere with study objectives

Design outcomes

Primary

Measure	Time frame
Change in inflammatory lesion count	0, 1, 3, 6, 9 and 12 weeks

Secondary

Measure	Time frame
Success on IGA defined as clear or almost clear	Week 12

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026