A 21 Day Pharmacokinetics Study in Papulopustular Rosacea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cutanea Life Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT02028286
First received: November 27, 2013
Last updated: April 11, 2014
Last verified: April 2014
  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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Cutanea Life Sciences, Inc.
ClinicalTrials.gov Identifier: NCT02028286     History of Changes
Other Study ID Numbers: CLS001-CO-PR-002
Study First Received: November 27, 2013
Last Updated: April 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cutanea Life Sciences, Inc.:
Rosacea

Additional relevant MeSH terms:
Rosacea
Skin Diseases

ClinicalTrials.gov processed this record on October 20, 2014