Trial Outcomes & Findings for Pulsed Dye Laser Treatment and Oxymetazoline Hydrochloride (HCL) 1% Cream for Erythematotelangiectatic Rosacea (NCT NCT04153188)

Last Updated: 2022-03-31

Results Overview

CEA was graded by the investigator according to 5-point scale (0=Clear to 4=Severe) for each patient at the 6-month post-baseline visits. A higher score indicates worse outcome. The outcomes presented here are the mean CEA calculated for the 6-month post-baseline visit of each arm.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

34 participants

Primary outcome timeframe

6-month post-baseline

Results posted on

2022-03-31

Participant Flow

Each subject was randomly assigned to receive either oxymetazoline therapy combined with three monthly 595-nm PDL treatments (Arm 1) or oxymetazoline therapy only (Arm 2). Accordingly, eighteen subjects were assigned to Arm 1 and sixteen subjects were assigned to Arm 2.

Four subjects dropped prior to 1 month post baseline visit (three subjects from Arm 2 and one subject from Arm 1). Therefore, thirty subjects are included in the analysis (17 subjects from Arm 1 and 13 subjects from Arm 2)

Participant milestones

Participant milestones
Measure	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream for 4 weeks prior to 1st of 3 monthly Vbeam® Prima PDL treatments. Subjects will continue with once daily application of Oxymetazoline HCL 1% Cream during the 6-month post-baseline study with a 3-day washout of cream prior to each of the 3 PDL treatments. The Vbeam® Prima System: 3 monthly Vbeam® Prima PDL treatments with a 3-day washout of topical Oxymetazoline HCL 1% cream before each treatment. Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study.	Oxymetazoline HCL 1% Cream Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream during the 6-month study. Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study.
Overall Study STARTED	17	13
Overall Study COMPLETED	14	11
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream for 4 weeks prior to 1st of 3 monthly Vbeam® Prima PDL treatments. Subjects will continue with once daily application of Oxymetazoline HCL 1% Cream during the 6-month post-baseline study with a 3-day washout of cream prior to each of the 3 PDL treatments. The Vbeam® Prima System: 3 monthly Vbeam® Prima PDL treatments with a 3-day washout of topical Oxymetazoline HCL 1% cream before each treatment. Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study.	Oxymetazoline HCL 1% Cream Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream during the 6-month study. Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study.
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	2	0
Overall Study Subject withdrew due to rebound erythema when Oxymetazoline wore off	0	1

Baseline Characteristics

Pulsed Dye Laser Treatment and Oxymetazoline Hydrochloride (HCL) 1% Cream for Erythematotelangiectatic Rosacea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream n=17 Participants Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream for 4 weeks prior to 1st of 3 monthly Vbeam® Prima PDL treatments. Subjects will continue with once daily application of Oxymetazoline HCL 1% Cream during the 6-month post-baseline study with a 3-day washout of cream prior to each of the 3 PDL treatments. The Vbeam® Prima System: 3 monthly Vbeam® Prima PDL treatments with a 3-day washout of topical Oxymetazoline HCL 1% cream before each treatment. Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study.	Oxymetazoline HCL 1% Cream n=13 Participants Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream during the 6-month study. Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=93 Participants	13 Participants n=4 Participants	30 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	44 years STANDARD_DEVIATION 12 • n=93 Participants	46 years STANDARD_DEVIATION 9 • n=4 Participants	45 years STANDARD_DEVIATION 11 • n=27 Participants
Sex: Female, Male Female	13 Participants n=93 Participants	10 Participants n=4 Participants	23 Participants n=27 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=93 Participants	12 Participants n=4 Participants	28 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	17 Participants n=93 Participants	12 Participants n=4 Participants	29 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	17 participants n=93 Participants	13 participants n=4 Participants	30 participants n=27 Participants
Clinical Erythema Assessment (CEA) Score	3.2 units on a scale STANDARD_DEVIATION 0.4 • n=93 Participants	3.2 units on a scale STANDARD_DEVIATION 0.4 • n=4 Participants	3.2 units on a scale STANDARD_DEVIATION 0.4 • n=27 Participants
Subject Self-Assessment	3.5 units on a scale STANDARD_DEVIATION 0.5 • n=93 Participants	3.6 units on a scale STANDARD_DEVIATION 0.5 • n=4 Participants	3.6 units on a scale STANDARD_DEVIATION 0.5 • n=27 Participants

PRIMARY outcome

Timeframe: 6-month post-baseline

Population: Arm 1- Two subjects dropped before 2-month post-baseline visit and one subject dropped before the 6-month post baseline visit. Arm 2- One subject dropped before 2-month post-baseline visit and one subject dropped before the 6-month post baseline visit.

Outcome measures

Outcome measures
Measure	Oxymetazoline HCL 1% Cream n=11 Participants Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream during the 6-month study. Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study.	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream n=14 Participants Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream for 4 weeks prior to 1st of 3 monthly Vbeam® Prima PDL treatments. Subjects will continue with once daily application of Oxymetazoline HCL 1% Cream during the 6-month post-baseline study with a 3-day washout of cream prior to each of the 3 PDL treatments. The Vbeam® Prima System: 3 monthly Vbeam® Prima PDL treatments with a 3-day washout of topical Oxymetazoline HCL 1% cream before each treatment. Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study.
Clinical Erythema Assessment (CEA) Score At 6-Month Post-Baseline	2.4 score on a scale Standard Deviation 1.0	1.6 score on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: 1- ,2- and 3-Month Post-Baseline Visits

Population: Arm 1- Two subjects dropped before 2-month post-baseline visit. Arm 2- One subject dropped before 2-month post-baseline visit.

Clinical Erythema Assessment (CEA) scores at the 1- ,2- and 3-month post-baseline visits were assessed for each patient by the investigator. CEA scores were graded according to 5-point scale (0=Clear to 4=Severe). A higher score indicates worse outcome. The outcomes presented here are the mean CEA calculated for each visit.

Outcome measures

Outcome measures
Measure	Oxymetazoline HCL 1% Cream n=13 Participants Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream during the 6-month study. Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study.	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream n=17 Participants Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream for 4 weeks prior to 1st of 3 monthly Vbeam® Prima PDL treatments. Subjects will continue with once daily application of Oxymetazoline HCL 1% Cream during the 6-month post-baseline study with a 3-day washout of cream prior to each of the 3 PDL treatments. The Vbeam® Prima System: 3 monthly Vbeam® Prima PDL treatments with a 3-day washout of topical Oxymetazoline HCL 1% cream before each treatment. Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study.
Clinical Erythema Assessment (CEA) At the 1- ,2- and 3-Month Post-Baseline Visits Clinical Erythema Assessment (CEA) At 1-Month Post-Baseline	2.6 score on a scale Standard Deviation 0.5	2.6 score on a scale Standard Deviation 0.8
Clinical Erythema Assessment (CEA) At the 1- ,2- and 3-Month Post-Baseline Visits Clinical Erythema Assessment (CEA) At 2-Month Post-Baseline	2.0 score on a scale Standard Deviation 0.6	2.5 score on a scale Standard Deviation 0.6
Clinical Erythema Assessment (CEA) At the 1- ,2- and 3-Month Post-Baseline Visits Clinical Erythema Assessment (CEA) At 3-Month Post-Baseline	2.3 score on a scale Standard Deviation 0.8	2.0 score on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: 1-, 2-, 3- and 6-months post-baseline

Subject Self-Assessment (SSA) at the 1- ,2-, 3- and 6-month post-baseline visits were graded according to 5-point scale (0=Clear of unwanted redness to 4=Completely unacceptable redness) at each visit. A higher score indicates worse outcome.

Outcome measures

Outcome measures
Measure	Oxymetazoline HCL 1% Cream n=13 Participants Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream during the 6-month study. Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study.	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream n=17 Participants Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream for 4 weeks prior to 1st of 3 monthly Vbeam® Prima PDL treatments. Subjects will continue with once daily application of Oxymetazoline HCL 1% Cream during the 6-month post-baseline study with a 3-day washout of cream prior to each of the 3 PDL treatments. The Vbeam® Prima System: 3 monthly Vbeam® Prima PDL treatments with a 3-day washout of topical Oxymetazoline HCL 1% cream before each treatment. Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study.
Subject Self-Assessment (SSA) At the 1- ,2-, 3- and 6-Month Post-Baseline Visits Subject Self-Assessment (SSA) At the 1-Month Post Baseline	3.0 score on a scale Standard Deviation 0.6	3.3 score on a scale Standard Deviation 0.8
Subject Self-Assessment (SSA) At the 1- ,2-, 3- and 6-Month Post-Baseline Visits Subject Self-Assessment (SSA) At the 2-Month Post Baseline	2.3 score on a scale Standard Deviation 0.7	2.7 score on a scale Standard Deviation 1.0
Subject Self-Assessment (SSA) At the 1- ,2-, 3- and 6-Month Post-Baseline Visits Subject Self-Assessment (SSA) At the 3-Month Post Baseline	2.3 score on a scale Standard Deviation 0.7	2.1 score on a scale Standard Deviation 1.1
Subject Self-Assessment (SSA) At the 1- ,2-, 3- and 6-Month Post-Baseline Visits Subject Self-Assessment (SSA) At the 6-Month Post Baseline	2.2 score on a scale Standard Deviation 0.9	1.4 score on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: 1-, 2-, 3- and 6-month post-baseline

Investigator measurement of Global Aesthetic Improvement (GAI) with treatment. GAI is graded according to 5-point scale (0=Excellent improvement to 4=No change). A higher score indicates a worse outcome. The outcomes presented here are the mean GAI calculated for each visit.

Outcome measures

Outcome measures
Measure	Oxymetazoline HCL 1% Cream n=13 Participants Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream during the 6-month study. Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study.	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream n=17 Participants Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream for 4 weeks prior to 1st of 3 monthly Vbeam® Prima PDL treatments. Subjects will continue with once daily application of Oxymetazoline HCL 1% Cream during the 6-month post-baseline study with a 3-day washout of cream prior to each of the 3 PDL treatments. The Vbeam® Prima System: 3 monthly Vbeam® Prima PDL treatments with a 3-day washout of topical Oxymetazoline HCL 1% cream before each treatment. Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study.
Mean Investigator Assessment of Global Aesthetic Improvement (GAI) Grades At the 1-, 2-, 3- and 6-Month Post-Baseline Mean GAI Grade at 1-Months Post-Baseline Visit	2.7 score on a scale Standard Deviation 1.0	2.5 score on a scale Standard Deviation 1.2
Mean Investigator Assessment of Global Aesthetic Improvement (GAI) Grades At the 1-, 2-, 3- and 6-Month Post-Baseline Mean GAI Grade at 2-Months Post-Baseline Visit	1.4 score on a scale Standard Deviation 1.0	2.3 score on a scale Standard Deviation 1.1
Mean Investigator Assessment of Global Aesthetic Improvement (GAI) Grades At the 1-, 2-, 3- and 6-Month Post-Baseline Mean GAI Grade at 3-Months Post-Baseline Visit	2.5 score on a scale Standard Deviation 1.6	1.7 score on a scale Standard Deviation 1.4
Mean Investigator Assessment of Global Aesthetic Improvement (GAI) Grades At the 1-, 2-, 3- and 6-Month Post-Baseline Mean GAI Grade at 6-Months Post-Baseline Visit	2.5 score on a scale Standard Deviation 1.3	1.2 score on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 1-, 2-, 3- and 6-month post-baseline

Subject measurement of Global Aesthetic Improvement (GAI) with treatment. GAI is graded according to 5-point scale (0=Excellent improvement to 4=No change). A higher score indicates a worse outcome. The outcomes presented here are the mean GAI calculated for each visit.

Outcome measures

Outcome measures
Measure	Oxymetazoline HCL 1% Cream n=13 Participants Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream during the 6-month study. Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study.	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream n=17 Participants Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream for 4 weeks prior to 1st of 3 monthly Vbeam® Prima PDL treatments. Subjects will continue with once daily application of Oxymetazoline HCL 1% Cream during the 6-month post-baseline study with a 3-day washout of cream prior to each of the 3 PDL treatments. The Vbeam® Prima System: 3 monthly Vbeam® Prima PDL treatments with a 3-day washout of topical Oxymetazoline HCL 1% cream before each treatment. Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study.
Mean Subject Assessment of Global Aesthetic Improvement (GAI) Grades At the 1-, 2-, 3- and 6-Month Post-Baseline Mean GAI Grade at 1-Months Post-Baseline Visit	2.9 units on a scale Standard Deviation 1.0	2.6 units on a scale Standard Deviation 1.0
Mean Subject Assessment of Global Aesthetic Improvement (GAI) Grades At the 1-, 2-, 3- and 6-Month Post-Baseline Mean GAI Grade at 2-Months Post-Baseline Visit	2.4 units on a scale Standard Deviation 0.7	1.9 units on a scale Standard Deviation 0.8
Mean Subject Assessment of Global Aesthetic Improvement (GAI) Grades At the 1-, 2-, 3- and 6-Month Post-Baseline Mean GAI Grade at 3-Months Post-Baseline Visit	2.6 units on a scale Standard Deviation 0.9	1.2 units on a scale Standard Deviation 1.0
Mean Subject Assessment of Global Aesthetic Improvement (GAI) Grades At the 1-, 2-, 3- and 6-Month Post-Baseline Mean GAI Grade at 6-Months Post-Baseline Visit	2.1 units on a scale Standard Deviation 0.9	0.7 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 1-, 2-, 3- and 6-month post-baseline

Investigator assessment of improvement in vessel size with treatment. Improvement in vessel size is graded according to 4-point scale (0=76-100% improvement (excellent) to 4=No response). A higher score indicates a worse outcome. Mean score was calculated for each visit.

Outcome measures

Outcome measures
Measure	Oxymetazoline HCL 1% Cream n=13 Participants Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream during the 6-month study. Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study.	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream n=17 Participants Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream for 4 weeks prior to 1st of 3 monthly Vbeam® Prima PDL treatments. Subjects will continue with once daily application of Oxymetazoline HCL 1% Cream during the 6-month post-baseline study with a 3-day washout of cream prior to each of the 3 PDL treatments. The Vbeam® Prima System: 3 monthly Vbeam® Prima PDL treatments with a 3-day washout of topical Oxymetazoline HCL 1% cream before each treatment. Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study.
Measurement of Improvement in Vessel Size At the 1-, 2-, 3- and 6-Month Post-Baseline Visits Mean Vessel Size Improvement Grade at 1-Month Post-Baseline Visit	3.2 score on a scale Standard Deviation 0.7	3.4 score on a scale Standard Deviation 0.9
Measurement of Improvement in Vessel Size At the 1-, 2-, 3- and 6-Month Post-Baseline Visits Mean Vessel Size Improvement Grade at 2-Month Post-Baseline Visit	2.7 score on a scale Standard Deviation 1.1	2.4 score on a scale Standard Deviation 1
Measurement of Improvement in Vessel Size At the 1-, 2-, 3- and 6-Month Post-Baseline Visits Mean Vessel Size Improvement Grade at 3-Month Post-Baseline Visit	3.1 score on a scale Standard Deviation 1.2	1.8 score on a scale Standard Deviation 1.1
Measurement of Improvement in Vessel Size At the 1-, 2-, 3- and 6-Month Post-Baseline Visits Mean Vessel Size Improvement Grade at 6-Month Post-Baseline Visit	3.1 score on a scale Standard Deviation 0.9	1.6 score on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: 6-month post-baseline

Subject satisfaction is graded according to 5-point scale (0=Very Satisfied to 4=Very Dissatisfied). Lower score indicates higher satisfaction. A score of 0 or 1 indicates satisfaction with treatment outcome. The measurements reflect the percentage of subjects that were satisfied (graded 0 or 1) at the 6-month post-baseline visit

Outcome measures

Outcome measures
Measure	Oxymetazoline HCL 1% Cream n=11 Participants Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream during the 6-month study. Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study.	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream n=14 Participants Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream for 4 weeks prior to 1st of 3 monthly Vbeam® Prima PDL treatments. Subjects will continue with once daily application of Oxymetazoline HCL 1% Cream during the 6-month post-baseline study with a 3-day washout of cream prior to each of the 3 PDL treatments. The Vbeam® Prima System: 3 monthly Vbeam® Prima PDL treatments with a 3-day washout of topical Oxymetazoline HCL 1% cream before each treatment. Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study.
Measurement of The Percentage of Subjects Reporting Satisfaction At the 6-Month Post-Baseline Visit	7 Participants	12 Participants

SECONDARY outcome

Timeframe: 1-, 2- and 3-month post-baseline

Population: Arm 1- Two subjects dropped before 2-month post-baseline visit. Therefore 17 subjects underwent the first treatment and 15 subjects underwent a second and third treatments.

A standard 10-centimeter visual analog scale from 0=No pain to 10=worst pain was used by subjects to report pain level associated with PDL treatment. A higher score indicates greater pain/discomfort with treatment. Mean of all pain associated scores obtained for all PDL treatments was calculated.

Outcome measures

Outcome measures
Measure	Oxymetazoline HCL 1% Cream Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream during the 6-month study. Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study.	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream n=47 PDL Treatments Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream for 4 weeks prior to 1st of 3 monthly Vbeam® Prima PDL treatments. Subjects will continue with once daily application of Oxymetazoline HCL 1% Cream during the 6-month post-baseline study with a 3-day washout of cream prior to each of the 3 PDL treatments. The Vbeam® Prima System: 3 monthly Vbeam® Prima PDL treatments with a 3-day washout of topical Oxymetazoline HCL 1% cream before each treatment. Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study.
Measurement of Pain Associated With PDL Treatment	—	4.5 score on a scale Standard Deviation 2.2

Adverse Events

Pulsed Dye Laser & Oxymetazoline HCL 1% Cream

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Oxymetazoline HCL 1% Cream

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream n=17 participants at risk Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream for 4 weeks prior to 1st of 3 monthly Vbeam® Prima PDL treatments. Subjects will continue with once daily application of Oxymetazoline HCL 1% Cream during the 6-month post-baseline study with a 3-day washout of cream prior to each of the 3 PDL treatments. The Vbeam® Prima System: 3 monthly Vbeam® Prima PDL treatments with a 3-day washout of topical Oxymetazoline HCL 1% cream before each treatment. Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study.	Oxymetazoline HCL 1% Cream n=13 participants at risk Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream during the 6-month study. Oxymetazoline HCL 1% Cream: Daily application of Oxymetazoline HCL 1% cream for the 6-month study.
Skin and subcutaneous tissue disorders Dryness	5.9% 1/17 • Number of events 1 • The period of time over which adverse event data were collected is from first visit until 6 month post baseline The number and severity of adverse events following Oxymetazoline and/or Pulsed Dye Laser treatments for Arm 1 (Pulsed Dye Laser \& Oxymetazoline HCL 1 % Cream) or following Oxymetazoline treatment for Arm 2 (Oxymetazoline HCL 1 % Cream). Adverse events were evaluated at each of the visits following baseline until the last visit (6 month post baseline).	7.7% 1/13 • Number of events 1 • The period of time over which adverse event data were collected is from first visit until 6 month post baseline The number and severity of adverse events following Oxymetazoline and/or Pulsed Dye Laser treatments for Arm 1 (Pulsed Dye Laser \& Oxymetazoline HCL 1 % Cream) or following Oxymetazoline treatment for Arm 2 (Oxymetazoline HCL 1 % Cream). Adverse events were evaluated at each of the visits following baseline until the last visit (6 month post baseline).
Skin and subcutaneous tissue disorders Tingling	0.00% 0/17 • The period of time over which adverse event data were collected is from first visit until 6 month post baseline The number and severity of adverse events following Oxymetazoline and/or Pulsed Dye Laser treatments for Arm 1 (Pulsed Dye Laser \& Oxymetazoline HCL 1 % Cream) or following Oxymetazoline treatment for Arm 2 (Oxymetazoline HCL 1 % Cream). Adverse events were evaluated at each of the visits following baseline until the last visit (6 month post baseline).	7.7% 1/13 • Number of events 1 • The period of time over which adverse event data were collected is from first visit until 6 month post baseline The number and severity of adverse events following Oxymetazoline and/or Pulsed Dye Laser treatments for Arm 1 (Pulsed Dye Laser \& Oxymetazoline HCL 1 % Cream) or following Oxymetazoline treatment for Arm 2 (Oxymetazoline HCL 1 % Cream). Adverse events were evaluated at each of the visits following baseline until the last visit (6 month post baseline).
Skin and subcutaneous tissue disorders Blistering	11.8% 2/17 • Number of events 2 • The period of time over which adverse event data were collected is from first visit until 6 month post baseline The number and severity of adverse events following Oxymetazoline and/or Pulsed Dye Laser treatments for Arm 1 (Pulsed Dye Laser \& Oxymetazoline HCL 1 % Cream) or following Oxymetazoline treatment for Arm 2 (Oxymetazoline HCL 1 % Cream). Adverse events were evaluated at each of the visits following baseline until the last visit (6 month post baseline).	0.00% 0/13 • The period of time over which adverse event data were collected is from first visit until 6 month post baseline The number and severity of adverse events following Oxymetazoline and/or Pulsed Dye Laser treatments for Arm 1 (Pulsed Dye Laser \& Oxymetazoline HCL 1 % Cream) or following Oxymetazoline treatment for Arm 2 (Oxymetazoline HCL 1 % Cream). Adverse events were evaluated at each of the visits following baseline until the last visit (6 month post baseline).
Skin and subcutaneous tissue disorders Edema and Erythema	5.9% 1/17 • Number of events 1 • The period of time over which adverse event data were collected is from first visit until 6 month post baseline The number and severity of adverse events following Oxymetazoline and/or Pulsed Dye Laser treatments for Arm 1 (Pulsed Dye Laser \& Oxymetazoline HCL 1 % Cream) or following Oxymetazoline treatment for Arm 2 (Oxymetazoline HCL 1 % Cream). Adverse events were evaluated at each of the visits following baseline until the last visit (6 month post baseline).	0.00% 0/13 • The period of time over which adverse event data were collected is from first visit until 6 month post baseline The number and severity of adverse events following Oxymetazoline and/or Pulsed Dye Laser treatments for Arm 1 (Pulsed Dye Laser \& Oxymetazoline HCL 1 % Cream) or following Oxymetazoline treatment for Arm 2 (Oxymetazoline HCL 1 % Cream). Adverse events were evaluated at each of the visits following baseline until the last visit (6 month post baseline).
Skin and subcutaneous tissue disorders Papules	5.9% 1/17 • Number of events 1 • The period of time over which adverse event data were collected is from first visit until 6 month post baseline The number and severity of adverse events following Oxymetazoline and/or Pulsed Dye Laser treatments for Arm 1 (Pulsed Dye Laser \& Oxymetazoline HCL 1 % Cream) or following Oxymetazoline treatment for Arm 2 (Oxymetazoline HCL 1 % Cream). Adverse events were evaluated at each of the visits following baseline until the last visit (6 month post baseline).	0.00% 0/13 • The period of time over which adverse event data were collected is from first visit until 6 month post baseline The number and severity of adverse events following Oxymetazoline and/or Pulsed Dye Laser treatments for Arm 1 (Pulsed Dye Laser \& Oxymetazoline HCL 1 % Cream) or following Oxymetazoline treatment for Arm 2 (Oxymetazoline HCL 1 % Cream). Adverse events were evaluated at each of the visits following baseline until the last visit (6 month post baseline).

Additional Information

Medical Director

Candela Corporation

Phone: +1 904 6549629

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place