A 21 Day Pharmacokinetics Study in Papulopustular Rosacea

A Phase 1, Open Label, Multiple Center Study to Evaluate the Pharmacokinetics of Once-Daily CLS001 Topical Gel Under Maximal Use Conditions Administered for 21 Days in Subjects With Papulopustular Rosacea

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02028286

Enrollment

Registered

2014-01-07

Start date

2014-01-31

Completion date

Unknown

Last updated

2014-04-14

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 characterize the pharmacokinetics of once daily topical gel and confirm that steady state conditions are reached under maximal use conditions following 3 weeks of daily applications.

Interventions

DRUGCLS001

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* A diagnosis of papulopustular rosacea * Grade 3 or 4 on the 5-point Investigator Global Assessment scale * Presence of telangiectasia

Exclusion criteria

* steroid rosacea or subtype 3 (phymatous rosacea) * clinically significant abnormal findings that would interfere with study objective or risk to safety for the subject. * nodular rosacea (lesions greater than 5mm with more than 2 modules)

Design outcomes

Primary

Measure	Time frame	Description
Plasma concentrations of CLS001 to determine pharmacokinetic parameters at visit 2, visit 3 and visit 5	24 days	Plasma concentrations of CLS001 to determine pharmacokinetic parameters at visit 2, visit 3 and visit 5.

Secondary

Measure	Time frame
incidence of adverse events	24 days

Countries

United States

Outcome results

None listed

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