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

• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Erythema; Rosacea	Drug: Oxymetazoline HCL Cream 1.0%; Drug: Vehicle to Oxymetazoline HCL Cream	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 445 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: June 2014
• Actual Primary Completion Date: April 2015
• Actual Study Completion Date: May 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Oxymetazoline HCL Cream 1.0%; Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.	Drug: Oxymetazoline HCL Cream 1.0%; Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 29 days.
Placebo Comparator: Vehicle; Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.	Drug: Vehicle to Oxymetazoline HCL Cream; Vehicle to Oxymetazoline HCL Cream (AGN-199201) applied to the face once daily for 29 days.

Outcome Measures

Primary Outcome Measures :

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 [ Time Frame: Baseline, Day 29 (Hours 3, 6, 9 and 12) ]
   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.

Secondary Outcome Measures :

1. 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 [ Time Frame: Baseline, Day 29 (Hours 3, 6, 9 and 12) ]
   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 SSA from Baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) post-dose on Day 29.
2. 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 [ Time Frame: Baseline, Day 29 (Hours 3, 6, 9 and 12) ]
   DIA of photographs was used to assess rosacea facial redness and was defined as percentage of facial area occupied by redness. A higher value in the percentage of facial area occupied by facial redness indicated more redness. A negative/ lower number percent change from Baseline indicates improvement.
3. 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 [ Time Frame: Day 29 (Hours 3, 6, 9 and 12) ]
   Participants assessed their treatment satisfaction by answering Item #9 of the SAT-RFR: "Right now, how satisfied are you with the effect your study medication had on your facial redness?" using a 5-point scale where 0= very dissatisfied, 1=dissatisfied, 2=neither satisfied or dissatisfied, 3=satisfied, or 4=very satisfied. The percentage of participants who answered Satisfied or Very Satisfied is reported.
4. 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 [ Time Frame: Baseline, Day 29 (Hours 3, 6, 9 and 12) ]
   Participants assessed the burning sensation associated with rosacea facial redness by answering Item #4 of the SA-RFR: "Right now, how much does your face burn because of your facial redness?" using a 5-point scale where 0=less severe to 4=severe. A negative change from Baseline indicates improvement.
5. Percentage of Participants With at Least a 1-Grade Improvement (Decrease) From Baseline on SSA at Hour 1 on Day 1 [ Time Frame: Baseline, Day 1 (Hour 1) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Texas

College Station, Texas, United States

Sponsors and Collaborators

Allergan

Investigators

• Study Director: Medical Director; Allergan

More Information

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT02132117 History of Changes
• Other Study ID Numbers: 199201-005
• First Posted: May 7, 2014
• Results First Posted: August 2, 2016
• Last Update Posted: August 2, 2016
• Last Verified: June 2016

Additional relevant MeSH terms:

Rosacea; Erythema; Skin Diseases; Skin Manifestations; Signs and Symptoms; Oxymetazoline; Phenylephrine; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Sympathomimetics; Autonomic Agents; Peripheral Nervous System Agents; Nasal Decongestants; Vasoconstrictor Agents; Respiratory System Agents; Cardiotonic Agents; Mydriatics; Adrenergic alpha-1 Receptor Agonists; Protective Agents