Trial Outcomes & Findings for Safety and Efficacy of Oxymetazoline HCl Cream 1.0% in Patients With Persistent Erythema Associated With Rosacea (NCT NCT02132117)
NCT ID: NCT02132117
Last Updated: 2019-11-18
Results Overview
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.
COMPLETED
PHASE3
445 participants
Baseline, Day 29 (Hours 3, 6, 9 and 12)
2019-11-18
Participant Flow
Participant milestones
| Measure |
Oxymetazoline HCL Cream 1.0%
Oxymetazoline hydrochloride (HCL) Cream 1.0% applied to the face once daily for 29 days.
|
Vehicle
Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
|
|---|---|---|
|
Overall Study
STARTED
|
224
|
221
|
|
Overall Study
COMPLETED
|
213
|
216
|
|
Overall Study
NOT COMPLETED
|
11
|
5
|
Reasons for withdrawal
| Measure |
Oxymetazoline HCL Cream 1.0%
Oxymetazoline hydrochloride (HCL) Cream 1.0% applied to the face once daily for 29 days.
|
Vehicle
Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Personal Reasons
|
1
|
2
|
|
Overall Study
Other Miscellaneous Reasons
|
2
|
0
|
Baseline Characteristics
Safety and Efficacy of Oxymetazoline HCl Cream 1.0% in Patients With Persistent Erythema Associated With Rosacea
Baseline characteristics by cohort
| Measure |
Oxymetazoline HCL Cream 1.0%
n=224 Participants
Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
|
Vehicle
n=221 Participants
Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
|
Total
n=445 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-64 years
|
198 participants
n=5 Participants
|
193 participants
n=7 Participants
|
391 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
26 participants
n=5 Participants
|
28 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
177 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
350 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 29 (Hours 3, 6, 9 and 12)Population: Intent-to-treat (ITT) Population included all randomized participants.
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.
Outcome measures
| Measure |
Oxymetazoline HCL Cream 1.0%
n=224 Participants
Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
|
Vehicle
n=221 Participants
Vehicle to Oxymetazoline HCL Cream 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
Day 29 (Hour 3)
|
14.3 percentage of participants
|
7.4 percentage of participants
|
|
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
|
4.8 percentage of participants
|
|
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
|
8.5 percentage of participants
|
|
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
|
6.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 29 (Hours 3, 6, 9 and 12)Population: ITT Population included all randomized participants.
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.
Outcome measures
| Measure |
Oxymetazoline HCL Cream 1.0%
n=224 Participants
Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
|
Vehicle
n=221 Participants
Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
|
|---|---|---|
|
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
|
15.8 percentage of participants
|
|
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
|
14.7 percentage of participants
|
|
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
|
16.0 percentage of participants
|
|
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
|
15.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 29 (Hours 3, 6, 9 and 12)Population: ITT Population included all randomized participants.
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.
Outcome measures
| Measure |
Oxymetazoline HCL Cream 1.0%
n=224 Participants
Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
|
Vehicle
n=221 Participants
Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
|
|---|---|---|
|
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 • Interval -100.0 to 1666.0
|
0.00 percent change in area of redness
Full Range 225.452 • Interval -94.1 to 2864.7
|
|
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 • Interval -100.0 to 1760.3
|
2.25 percent change in area of redness
Full Range 198.138 • Interval -92.3 to 2037.4
|
|
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 • Interval -100.0 to 1067.2
|
5.15 percent change in area of redness
Full Range 200.530 • Interval -89.4 to 2037.4
|
|
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 • Interval -100.0 to 1486.9
|
1.00 percent change in area of redness
Full Range 195.291 • Interval -96.3 to 2037.4
|
SECONDARY outcome
Timeframe: Day 29 (Hours 3, 6, 9 and 12)Population: Participants from the ITT Population, all randomized participants with data available for analysis.
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.
Outcome measures
| Measure |
Oxymetazoline HCL Cream 1.0%
n=223 Participants
Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
|
Vehicle
n=220 Participants
Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
|
|---|---|---|
|
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
|
34.1 percentage of participants
|
|
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
|
32.3 percentage of participants
|
|
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
|
33.6 percentage of participants
|
|
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
|
36.4 percentage of participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Oxymetazoline HCL Cream 1.0%
n=129 Participants
Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
|
Vehicle
n=134 Participants
Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
|
|---|---|---|
|
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
|
-1.6 score on a scale
Standard Deviation 0.91
|
|
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
|
-1.6 score on a scale
Standard Deviation 0.93
|
|
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
|
-1.7 score on a scale
Standard Deviation 0.96
|
|
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
|
-1.7 score on a scale
Standard Deviation 0.91
|
SECONDARY outcome
Timeframe: Baseline, Day 1 (Hour 1)Population: ITT Population included all randomized participants.
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.
Outcome measures
| Measure |
Oxymetazoline HCL Cream 1.0%
n=224 Participants
Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
|
Vehicle
n=221 Participants
Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
|
|---|---|---|
|
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
|
16.8 percentage of participants
|
Adverse Events
Oxymetazoline HCL Cream 1.0%
Vehicle
Serious adverse events
| Measure |
Oxymetazoline HCL Cream 1.0%
n=223 participants at risk
Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
|
Vehicle
n=221 participants at risk
Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
|
|---|---|---|
|
Endocrine disorders
Goitre
|
0.00%
0/223
Safety Population, all participants who applied at least one dose of study medication, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.45%
1/221
Safety Population, all participants who applied at least one dose of study medication, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/223
Safety Population, all participants who applied at least one dose of study medication, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.45%
1/221
Safety Population, all participants who applied at least one dose of study medication, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.45%
1/223
Safety Population, all participants who applied at least one dose of study medication, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/221
Safety Population, all participants who applied at least one dose of study medication, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/223
Safety Population, all participants who applied at least one dose of study medication, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.45%
1/221
Safety Population, all participants who applied at least one dose of study medication, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/223
Safety Population, all participants who applied at least one dose of study medication, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.45%
1/221
Safety Population, all participants who applied at least one dose of study medication, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/223
Safety Population, all participants who applied at least one dose of study medication, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.45%
1/221
Safety Population, all participants who applied at least one dose of study medication, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/223
Safety Population, all participants who applied at least one dose of study medication, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.45%
1/221
Safety Population, all participants who applied at least one dose of study medication, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.00%
0/223
Safety Population, all participants who applied at least one dose of study medication, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.45%
1/221
Safety Population, all participants who applied at least one dose of study medication, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.45%
1/223
Safety Population, all participants who applied at least one dose of study medication, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/221
Safety Population, all participants who applied at least one dose of study medication, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.45%
1/223
Safety Population, all participants who applied at least one dose of study medication, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/221
Safety Population, all participants who applied at least one dose of study medication, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/223
Safety Population, all participants who applied at least one dose of study medication, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.45%
1/221
Safety Population, all participants who applied at least one dose of study medication, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER