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A 21 Day Pharmacokinetics Study in Papulopustular Rosacea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02028286
First Posted: January 7, 2014
Last Update Posted: April 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cutanea Life Sciences, Inc.
  Purpose
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.

Condition Intervention Phase
Papulopustular Rosacea Drug: CLS001 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Cutanea Life Sciences, Inc.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • incidence of adverse events [ Time Frame: 24 days ]

Enrollment: 25
Study Start Date: January 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CLS001
CLS001
Drug: CLS001

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02028286


Locations
United States, New Jersey
Frontage Clinical Services
Hackensack, New Jersey, United States, 07601
United States, Texas
Derm Research
Austin, Texas, United States
Sponsors and Collaborators
Cutanea Life Sciences, Inc.
  More Information

Responsible Party: Cutanea Life Sciences, Inc.
ClinicalTrials.gov Identifier: NCT02028286     History of Changes
Other Study ID Numbers: CLS001-CO-PR-002
First Submitted: November 27, 2013
First Posted: January 7, 2014
Last Update Posted: April 14, 2014
Last Verified: April 2014

Keywords provided by Cutanea Life Sciences, Inc.:
Rosacea

Additional relevant MeSH terms:
Rosacea
Skin Diseases