Safety and Efficacy of Oxymetazoline HCl Cream 1.0% in Patients With Persistent Erythema Associated With Rosacea
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02132117 |
Recruitment Status :
Completed
First Posted : May 7, 2014
Results First Posted : August 2, 2016
Last Update Posted : November 18, 2019
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Erythema Rosacea | Drug: Oxymetazoline HCL Cream 1.0% Drug: Vehicle to Oxymetazoline HCL Cream | Phase 3 |
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 |

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. |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132117
United States, Texas | |
College Station, Texas, United States |
Study Director: | Medical Director | Allergan |
Responsible Party: | Allergan |
ClinicalTrials.gov Identifier: | NCT02132117 |
Other Study ID Numbers: |
199201-005 |
First Posted: | May 7, 2014 Key Record Dates |
Results First Posted: | August 2, 2016 |
Last Update Posted: | November 18, 2019 |
Last Verified: | November 2019 |
Rosacea Erythema Skin Diseases Skin Manifestations Phenylephrine Oxymetazoline 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 |