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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02028286
Other study ID # CLS001-CO-PR-002
Secondary ID
Status Completed
Phase Phase 1
First received November 27, 2013
Last updated April 11, 2014
Start date January 2014

Study information

Verified date April 2014
Source Cutanea Life Sciences, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
CLS001


Locations

Country Name City State
United States Derm Research Austin Texas
United States Frontage Clinical Services Hackensack New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Cutanea Life Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 24 days Yes
Secondary incidence of adverse events 24 days Yes
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