Efficacy and Safety of AGN-199201 in Patients With Persistent Erythema Associated With Rosacea

NCT ID: NCT02131636

Last Updated: 2019-11-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will evaluate the safety and efficacy of AGN-199201 once daily compared to vehicle for the treatment of persistent moderate to severe facial erythema associated with rosacea.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Erythema Rosacea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AGN-199201

AGN-199201 applied to the face once daily for 29 days.

Group Type EXPERIMENTAL

AGN-199201

Intervention Type DRUG

AGN-199201 applied to the face once daily for 29 days.

Vehicle

Vehicle to AGN-199201 applied to the face once daily for 29 days.

Group Type PLACEBO_COMPARATOR

Vehicle to AGN-199201

Intervention Type DRUG

Vehicle to AGN-199201 applied to the face once daily for 29 days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AGN-199201

AGN-199201 applied to the face once daily for 29 days.

Intervention Type DRUG

Vehicle to AGN-199201

Vehicle to AGN-199201 applied to the face once daily for 29 days.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

-Moderate to severe persistent facial erythema associated with rosacea.

Exclusion Criteria

* Greater than 3 inflammatory lesions on the face
* Current treatment with monoamine oxidase (MAO) inhibitors
* Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scleroderma or Sjogren's syndrome.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Lynchburg, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

199201-004

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Safety and Efficacy Study to Evaluate Rosacea
NCT03883945 WITHDRAWN PHASE1/PHASE2
A Study of DER 45-EV Gel to Treat Rosacea
NCT00940992 COMPLETED PHASE2