- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02028286
A 21 Day Pharmacokinetics Study in Papulopustular Rosacea
April 11, 2014 updated by: Maruho Co., Ltd.
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- Frontage Clinical Services
-
-
Texas
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Austin, Texas, United States
- Derm Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CLS001
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
incidence of adverse events
Time Frame: 24 days
|
24 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
November 27, 2013
First Submitted That Met QC Criteria
January 3, 2014
First Posted (Estimate)
January 7, 2014
Study Record Updates
Last Update Posted (Estimate)
April 14, 2014
Last Update Submitted That Met QC Criteria
April 11, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLS001-CO-PR-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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