Erythema, Rosacea
Conditions
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.
Interventions
Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 29 days.
DRUGVehicle to Oxymetazoline HCL Cream
Vehicle to Oxymetazoline HCL Cream (AGN-199201) applied to the face once daily for 29 days.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 | 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 | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxymetazoline HCL Cream 1.0% Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days. | 224 |
| Vehicle Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days. | 221 |
| Total | 445 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 1 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Other Miscellaneous Reasons | 2 | 0 |
| Overall Study | Personal Reasons | 1 | 2 |
Baseline characteristics
| Characteristic | Oxymetazoline HCL Cream 1.0% | Vehicle | Total |
|---|---|---|---|
| Age, Customized 18-64 years | 198 participants | 193 participants | 391 participants |
| Age, Customized >=65 years | 26 participants | 28 participants | 54 participants |
| Sex: Female, Male Female | 177 Participants | 173 Participants | 350 Participants |
| Sex: Female, Male Male | 47 Participants | 48 Participants | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 223 | 0 / 221 |
| serious Total, serious adverse events | 3 / 223 | 2 / 221 |
Outcome results
Primary
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.
Time frame: Baseline, Day 29 (Hours 3, 6, 9 and 12)
Population: Intent-to-treat (ITT) Population included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Oxymetazoline HCL Cream 1.0% | 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 | Day 29 (Hour 9) | 15.5 percentage of participants |
| Oxymetazoline HCL Cream 1.0% | 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 | Day 29 (Hour 6) | 13.4 percentage of participants |
| Oxymetazoline HCL Cream 1.0% | 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 | Day 29 (Hour 12) | 12.3 percentage of participants |
| Oxymetazoline HCL Cream 1.0% | 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 | Day 29 (Hour 3) | 14.3 percentage of participants |
| Vehicle | 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 | Day 29 (Hour 12) | 6.1 percentage of participants |
| Vehicle | 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 | Day 29 (Hour 6) | 4.8 percentage of participants |
| Vehicle | 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 | Day 29 (Hour 9) | 8.5 percentage of participants |
| Vehicle | 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 | Day 29 (Hour 3) | 7.4 percentage of participants |
Secondary
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
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.
Time frame: Baseline, Day 29 (Hours 3, 6, 9 and 12)
Population: Participants from the ITT Population, all randomized participants, with data available for analysis at the given time-point. Only participants who had a SA-RFR score of 1-4 at Baseline are included in the Analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxymetazoline HCL Cream 1.0% | 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 | Day 29 (Hour 3) | -1.8 score on a scale | Standard Deviation 0.97 |
| Oxymetazoline HCL Cream 1.0% | 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 | Day 29 (Hour 6) | -1.8 score on a scale | Standard Deviation 0.93 |
| Oxymetazoline HCL Cream 1.0% | 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 | Day 29 (Hour 9) | -1.8 score on a scale | Standard Deviation 0.91 |
| Oxymetazoline HCL Cream 1.0% | 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 | Day 29 (Hour 12) | -1.8 score on a scale | Standard Deviation 0.92 |
| Vehicle | 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 | Day 29 (Hour 12) | -1.7 score on a scale | Standard Deviation 0.91 |
| Vehicle | 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 | Day 29 (Hour 3) | -1.6 score on a scale | Standard Deviation 0.93 |
| Vehicle | 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 | Day 29 (Hour 9) | -1.7 score on a scale | Standard Deviation 0.96 |
| Vehicle | 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 | Day 29 (Hour 6) | -1.6 score on a scale | Standard Deviation 0.91 |
Secondary
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
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.
Time frame: Day 29 (Hours 3, 6, 9 and 12)
Population: Participants from the ITT Population, all randomized participants with data available for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Oxymetazoline HCL Cream 1.0% | 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 (Hour 3) | 54.3 percentage of participants |
| Oxymetazoline HCL Cream 1.0% | 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 (Hour 6) | 49.3 percentage of participants |
| Oxymetazoline HCL Cream 1.0% | 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 (Hour 9) | 49.8 percentage of participants |
| Oxymetazoline HCL Cream 1.0% | 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 (Hour 12) | 47.5 percentage of participants |
| Vehicle | 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 (Hour 12) | 36.4 percentage of participants |
| Vehicle | 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 (Hour 3) | 34.1 percentage of participants |
| Vehicle | 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 (Hour 9) | 33.6 percentage of participants |
| Vehicle | 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 (Hour 6) | 32.3 percentage of participants |
Secondary
Percentage of Participants With at Least a 1-Grade Improvement (Decrease) From Baseline on SSA at Hour 1 on Day 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.
Time frame: Baseline, Day 1 (Hour 1)
Population: ITT Population included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oxymetazoline HCL Cream 1.0% | Percentage of Participants With at Least a 1-Grade Improvement (Decrease) From Baseline on SSA at Hour 1 on Day 1 | 29.7 percentage of participants |
| Vehicle | Percentage of Participants With at Least a 1-Grade Improvement (Decrease) From Baseline on SSA at Hour 1 on Day 1 | 16.8 percentage of participants |
Secondary
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
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.
Time frame: Baseline, Day 29 (Hours 3, 6, 9 and 12)
Population: ITT Population included all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Oxymetazoline HCL Cream 1.0% | 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 | Day 29 (Hour 3) | 24.1 percentage of participants |
| Oxymetazoline HCL Cream 1.0% | 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 | Day 29 (Hour 6) | 24.8 percentage of participants |
| Oxymetazoline HCL Cream 1.0% | 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 | Day 29 (Hour 9) | 22.0 percentage of participants |
| Oxymetazoline HCL Cream 1.0% | 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 | Day 29 (Hour 12) | 23.7 percentage of participants |
| Vehicle | 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 | Day 29 (Hour 12) | 15.8 percentage of participants |
| Vehicle | 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 | Day 29 (Hour 3) | 15.8 percentage of participants |
| Vehicle | 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 | Day 29 (Hour 9) | 16.0 percentage of participants |
| Vehicle | 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 | Day 29 (Hour 6) | 14.7 percentage of participants |
Secondary
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
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.
Time frame: Baseline, Day 29 (Hours 3, 6, 9 and 12)
Population: ITT Population included all randomized participants.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Oxymetazoline HCL Cream 1.0% | 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 | Day 29 (Hour 9) | -10.95 percent change in area of redness | Full Range 131.933 |
| Oxymetazoline HCL Cream 1.0% | 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 | Day 29 (Hour 6) | -15.95 percent change in area of redness | Full Range 170.735 |
| Oxymetazoline HCL Cream 1.0% | 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 | Day 29 (Hour 12) | -9.60 percent change in area of redness | Full Range 145.898 |
| Oxymetazoline HCL Cream 1.0% | 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 | Day 29 (Hour 3) | -25.70 percent change in area of redness | Full Range 144.776 |
| Vehicle | 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 | Day 29 (Hour 12) | 1.00 percent change in area of redness | Full Range 195.291 |
| Vehicle | 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 | Day 29 (Hour 6) | 2.25 percent change in area of redness | Full Range 198.138 |
| Vehicle | 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 | Day 29 (Hour 9) | 5.15 percent change in area of redness | Full Range 200.53 |
| Vehicle | 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 | Day 29 (Hour 3) | 0.00 percent change in area of redness | Full Range 225.452 |