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A 21 Day Pharmacokinetics Study in Papulopustular Rosacea

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ClinicalTrials.gov Identifier: NCT02028286
Recruitment Status : Completed
First Posted : January 7, 2014
Last Update Posted : April 14, 2014
Sponsor:
Information provided by (Responsible Party):
Cutanea Life Sciences, Inc.

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.

Condition or disease Intervention/treatment Phase
Papulopustular Rosacea Drug: CLS001 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
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
Study Start Date : January 2014
Actual Primary Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea
U.S. FDA Resources

Arm Intervention/treatment
Experimental: CLS001
CLS001
Drug: CLS001



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


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)

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.

Responsible Party: Cutanea Life Sciences, Inc.
ClinicalTrials.gov Identifier: NCT02028286     History of Changes
Other Study ID Numbers: CLS001-CO-PR-002
First Posted: January 7, 2014    Key Record Dates
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