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OpenTrials
Completed

NCT Number: NCT02028286

A 21 Day Pharmacokinetics Study in Papulopustular Rosacea

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.

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Key information

Conditions

Papulopustular Rosacea Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Frontage Clinical Services, Hackensack, New Jersey, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CLS001

Drug

Primary outcomes

  1. Plasma concentrations of CLS001 to determine pharmacokinetic parameters at visit 2, visit 3 and visit 5

    Time frame: 24 days

    Plasma concentrations of CLS001 to determine pharmacokinetic parameters at visit 2, visit 3 and visit 5.

Secondary outcomes

  1. incidence of adverse events

    Time frame: 24 days

Sponsors and collaborators

Lead sponsor

Maruho Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
First posted
Jan 7, 2014
Registry last updated
Apr 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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