Back to resultsA 21 Day Pharmacokinetics Study in Papulopustular Rosacea
Primary Purpose
Papulopustular Rosacea
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CLS001
Sponsored by
About this trial
This is an interventional treatment trial for Papulopustular Rosacea focused on measuring Rosacea
Eligibility 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)
Sites / Locations
- Frontage Clinical Services
- Derm Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CLS001
Arm Description
CLS001
Outcomes
Primary Outcome Measures
Plasma concentrations of CLS001 to determine pharmacokinetic parameters at visit 2, visit 3 and visit 5
Plasma concentrations of CLS001 to determine pharmacokinetic parameters at visit 2, visit 3 and visit 5.
Secondary Outcome Measures
incidence of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02028286
Brief Title
A 21 Day Pharmacokinetics Study in Papulopustular Rosacea
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 Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maruho Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papulopustular Rosacea
Keywords
Rosacea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CLS001
Arm Type
Experimental
Arm Description
CLS001
Intervention Type
Drug
Intervention Name(s)
CLS001
Primary Outcome Measure Information:
Title
Plasma concentrations of CLS001 to determine pharmacokinetic parameters at visit 2, visit 3 and visit 5
Description
Plasma concentrations of CLS001 to determine pharmacokinetic parameters at visit 2, visit 3 and visit 5.
Time Frame
24 days
Secondary Outcome Measure Information:
Title
incidence of adverse events
Time Frame
24 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
Frontage Clinical Services
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Derm Research
City
Austin
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A 21 Day Pharmacokinetics Study in Papulopustular Rosacea
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