Safety and Efficacy of Oxymetazoline HCl Cream 1.0% in Patients With Persistent Erythema Associated With Rosacea

NCT02132117 | Completed Phase 3 Results

• 1 other identifier: 199201-005
• Study Type: interventional
• Target: 445
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety and efficacy of oxymetazoline hydrochloride (HCl) cream 1.0% (AGN-199201) once daily compared to vehicle for the treatment of persistent moderate to severe facial erythema associated with rosacea.

Conditions

Erythema; Rosacea

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment for Rosacea Facial Redness (SSA) 5-point Scales

  The investigator assessed the participant's overall severity of erythema in the treatment area by using the 5-point CEA scale with photonumeric guide where: 0=clear skin with no signs of erythema (best) to 4=severe erythema; fiery redness (worst). A decrease in the score indicates improvement. The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. The percentage of participants with at least a 2-grade decrease (improvement) on both CEA and SSA from Baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) post-dose on Day 29. Baseline was defined as the measurement at pre-dose on Day 1.

  Baseline, Day 29 (Hours 3, 6, 9 and 12)

Secondary Outcomes (5)

• Percentage of Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on SSA at Hours 3, 6, 9 and 12 on Day 29

  Baseline, Day 29 (Hours 3, 6, 9 and 12)

• Percent Change From Baseline on Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA) at Hours 3, 6, 9 and 12 on Day 29

  Baseline, Day 29 (Hours 3, 6, 9 and 12)

• Percentage of Participants Satisfied or Very Satisfied on Item #9 of Satisfaction Assessment for Rosacea Facial Redness (SAT-RFR) at Hours 3, 6, 9 and 12 on Day 29

  Day 29 (Hours 3, 6, 9 and 12)

• Change From Baseline on the Symptom Assessment for Rosacea Facial Redness (SA-RFR) Item # 4 at Hours 3, 6, 9 and 12 on Day 29

  Baseline, Day 29 (Hours 3, 6, 9 and 12)

• Percentage of Participants With at Least a 1-Grade Improvement (Decrease) From Baseline on SSA at Hour 1 on Day 1

  Baseline, Day 1 (Hour 1)

Study Arms (2)

Oxymetazoline HCL Cream 1.0%

EXPERIMENTAL

Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.

Drug: Oxymetazoline HCL Cream 1.0%

Vehicle

PLACEBO COMPARATOR

Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.

Drug: Vehicle to Oxymetazoline HCL Cream

Interventions

Oxymetazoline HCL Cream 1.0% DRUG

Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 29 days.

Oxymetazoline HCL Cream 1.0%

Vehicle to Oxymetazoline HCL Cream DRUG

Vehicle to Oxymetazoline HCL Cream (AGN-199201) applied to the face once daily for 29 days.

Vehicle

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:

• 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

College Station, Texas, 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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: May 7, 2014
• Study Start: June 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 18, 2019
• Results First Posted: August 2, 2016

Record last verified: 2019-11

Locations

US (1)