A 21 Day Pharmacokinetics Study in Papulopustular Rosacea

Papulopustular Rosacea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02028286
• Other study ID #: CLS001-CO-PR-002
• 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. 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

• Papulopustular Rosacea
• Rosacea

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