A Long-Term Safety and Efficacy Study AGN-19920 in Patients With Persistent Erythema Associated With Rosacea

NCT02095158 | Completed Phase 3 Results

• 1 other identifier: 199201-006
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the long-term safety and efficacy of oxymetazoline hydrogen chloride (HCL) Cream 1.0% (AGN-199201) in patients with persistent erythema associated with rosacea.

Conditions

Erythema; Rosacea

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Treatment-Related Adverse Events

  An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A Treatment-Related Adverse Event is an Adverse Event determined by the investigator to be causally related to the study medication.

  56 Weeks

Secondary Outcomes (1)

• Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales

  Baseline, Day 1 Hours 3 and 6, Week 4 Predose and Hours 3 and 6, Week 12 Predose, Week 26 Predose and Hours 3 and 6, Week 39 Predose, Week 52 Predose and Hours 3 and 6, Week 54 Predose

Study Arms (1)

Oxymetazoline HCL Cream 1.0%

EXPERIMENTAL

Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.

Drug: Oxymetazoline HCL Cream 1.0%

Interventions

Oxymetazoline HCL Cream 1.0% DRUG

Oxymetazoline HCL Cream 1.0% applied to the face once daily for 52 weeks.

Also known as: AGN-199201

Oxymetazoline HCL Cream 1.0%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate to severe persistent facial erythema associated with rosacea.

You may not qualify if:

• Current treatment with monoamine oxidase (MAO) inhibitors
• Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scleroderma or Sjogren's syndrome.

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Portland, Oregon, United States

Location

MeSH Terms

Conditions

Erythema; Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: March 24, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 18, 2019
• Results First Posted: September 21, 2016

Record last verified: 2019-11

Locations

US (1)