NCT02028286

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Last Updated

April 14, 2014

Status Verified

April 1, 2014

Enrollment Period

2 months

First QC Date

November 27, 2013

Last Update Submit

April 11, 2014

Conditions

Papulopustular Rosacea

Keywords

Rosacea

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • incidence of adverse events

    24 days

Study Arms (1)

CLS001

EXPERIMENTAL

CLS001

Drug: CLS001

Interventions

CLS001DRUG
CLS001

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A diagnosis of papulopustular rosacea
  • Grade 3 or 4 on the 5-point Investigator Global Assessment scale
  • Presence of telangiectasia

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Frontage Clinical Services

Hackensack, New Jersey, 07601, United States

Location

Derm Research

Austin, Texas, United States

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2013

First Posted

January 7, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2014

Last Updated

April 14, 2014

Record last verified: 2014-04

Locations

US(2)