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

• Sponsor: Candela Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04153188
• Collaborator: (none)
• Enrollment: 34
• Locations: 2
• Arms: 2
• Actual Duration (Months): 23.7
• Patients Per Site: 17
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This study will compare treatment outcome with pulsed dye laser, when used used as an adjunctive treatment to oxymetazoline HCl 1% cream, compared to oxymetazoline HCL 1% cream alone, for patients with moderate or severe erythematotelangiectatic rosacea.

Condition or Disease	Intervention/Treatment	Phase
Erythematotelangiectatic Rosacea	Device: The Vbeam® Prima System; Drug: Oxymetazoline HCL 1% Cream	Phase 4

Detailed Description

This is a prospective, two-arm randomized, baseline-controlled, pilot study to evaluate treatment outcome of 3 Vbeam® Prima PDL treatments in subjects applying once-daily RHOFADE® topical oxymetazoline HCL 1.0% cream for improvement in erythematotelangiectatic rosacea. Treatment outcome will be compared to oxymetazoline HCL 1% cream alone.

Subjects with moderate or severe (Grade 3 or 4) erythematotelangiectatic rosacea on the validated Clinical Erythema Assessment (CEA) Scale and Subject Self-Assessment (SSA) Scale will be enrolled and randomized to one of two study arms:

Arm 1- 3 monthly treatments with Vbeam® PDL with daily RHOFADE® topical oxymetazoline HCL 1.0% cream.

Arm 2 -Treatment with daily RHOFADE® topical oxymetazoline HCL 1.0% cream only.

All subjects will apply RHOFADE® cream daily during the 6-month study. After 1-month of RHOFADE® cream, subjects in the combined treatment Arm 1 will receive the first of three monthly Vbeam® PDL treatments (at 4-week intervals) with a 3-day washout of cream before each treatment.

Investigators will assess erythema severity, global aesthetic improvement and vessel size improvement with treatment at 1, 2, 3 and 6-months' post-baseline. Subject satisfaction will be assessed. Safety assessments will be conducted at each study visit, and subjects in Arm 1 will also be assessed for treatment-associated discomfort and post-treatment response following PDL treatments.

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Subjects randomized at baseline to either 3 monthly treatments with PDL and daily oxymetazoline 1.0% cream (Arm 1) or oxymetazoline cream alone (Arm 2).Subjects randomized at baseline to either 3 monthly treatments with PDL and daily oxymetazoline 1.0% cream (Arm 1) or oxymetazoline cream alone (Arm 2).
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Study to Evaluate Vbeam® Prima Pulsed Dye Laser (PDL) Treatment and RHOFADE® (Oxymetazoline HCL, 1% Cream) for Erythematotelangiectatic Rosacea
• Actual Study Start Date: Jan 15, 2019
• Actual Primary Completion Date: Nov 13, 2020
• Actual Study Completion Date: Jan 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: The Vbeam® Prima System; 3 monthly Vbeam® Prima PDL treatments with a 3-day washout of topical Oxymetazoline HCL 1% cream before each treatment.; Other Names: Vbeam® Prima Pulsed Dye Laser Treatment Pulsed Dye Laser Treatment PDL Treatment ; Drug: Oxymetazoline HCL 1% Cream; Daily application of Oxymetazoline HCL 1% cream for the 6-month study.; Other Names: RHOFADE®
Active Comparator: Oxymetazoline HCL 1% Cream Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream during the 6-month study.	Drug: Oxymetazoline HCL 1% Cream; Daily application of Oxymetazoline HCL 1% cream for the 6-month study.; Other Names: RHOFADE®

Outcome Measures

Primary Outcome Measures

1. Clinical Erythema Assessment (CEA) Score At 6-Month Post-Baseline [6-month post-baseline]

   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.

Secondary Outcome Measures

1. Clinical Erythema Assessment (CEA) At the 1- ,2- and 3-Month Post-Baseline Visits [1- ,2- and 3-Month Post-Baseline Visits]

   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.

2. Subject Self-Assessment (SSA) At the 1- ,2-, 3- and 6-Month Post-Baseline Visits [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.

3. Mean Investigator Assessment of Global Aesthetic Improvement (GAI) Grades At the 1-, 2-, 3- and 6-Month Post-Baseline [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.

4. Mean Subject Assessment of Global Aesthetic Improvement (GAI) Grades At the 1-, 2-, 3- and 6-Month Post-Baseline [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.

5. Measurement of Improvement in Vessel Size At the 1-, 2-, 3- and 6-Month Post-Baseline Visits [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.

6. Measurement of The Percentage of Subjects Reporting Satisfaction At the 6-Month Post-Baseline Visit [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

7. Measurement of Pain Associated With PDL Treatment [1-, 2- and 3-month post-baseline]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Subject is a healthy male or female of 18 to 75 years of age.

2. Subject has erythematotelangiectatic rosacea with clinician erythema assessment (CEA) and subject self-assessment (SSA) of "moderate" or "severe" (Grade 3 or 4).

3. Fitzpatrick Skin Type I - VI.

4. Subject must be able to read, understand and sign the Informed Consent Form.

5. Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.

6. Subject must be willing to have limited sun exposure for the duration of the study, including the follow-up period up to 6 months post-baseline.

7. Subject is willing to have photographs taken of the treated area that will be used, de-identified, in evaluations and may be used, de-identified, in presentations and/or publications.

8. For female candidates - subject must be post-menopausal, or surgically sterilized, or using a medically acceptable form of birth control during the entire course of the study.

Exclusion Criteria:

1. Subject is pregnant or planning to become pregnant during the study duration.

2. Subject has an active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.

3. Subject has an implant in the treated area (such as metal plates or screws) or an injected chemical substance.

4. Subject has a known collagen (connective tissue) disorder, vascular disease, scleroderma or other autoimmune disease (i.e. rheumatoid arthritis, lupus).

5. Subject has a history of diseases stimulated by heat or sun exposure, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.

6. Subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.

7. Having or undergoing any form of treatment for active cancer or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.

8. Subject is suffering from significant concurrent illness, such as such as cardiac disorders, diabetes (type I or II), or pertinent neurological disorders.

9. Subject has an infection or is suffering from current or has a history of significant skin conditions in the treated area or inflammatory skin conditions, including, but not limited to: photodermatoses, active acne, excessive skin dryness, psoriasis, eczema, rash, open wounds, varicella scars, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course.

10. Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use might be requested as per the subject's physician discretion).

11. Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after each treatment session.

12. Subject has a history of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.

13. Subject has a history of keloid scarring or of abnormal wound healing.

14. Subject has a known photosensitivity to the device's laser wavelengths, history of ingesting medications known to induce photosensitivity, or history of seizure disorders due to light.

15. Subject has undergone any surgical, light-based therapy or radiofrequency (RF) procedures in the treatment area within 3 months of treatment or during the study.

16. Having undergone any other surgery in the treated area within 3 months of treatment (or more if skin has not healed completely) or during the study.

17. Subject has a tattoo or permanent make-up in the treated area.

18. Subject has systemically used retinoids or antioxidants within 1 month of treatment or during the study.

19. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.

20. Participation in a study of another device or drug within three months prior to enrollment or during the study.

21. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dermatology, Laser & Vein Specialists of the Carolinas	Charlotte	North Carolina	United States	28207
2	Dermatology & Laser Surgery Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• Candela Corporation

Investigators

• Study Director: Konika P Schallen, MD, Candela Corporation

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 11, 2018

More Information

Publications

• Bernstein EF, Schomacker K, Paranjape A, Jones CJ. Pulsed dye laser treatment of rosacea using a novel 15 mm diameter treatment beam. Lasers Surg Med. 2018 Oct;50(8):808-812. doi: 10.1002/lsm.22819. Epub 2018 Apr 10.
• DuBois J, Dover JS, Jones TM, Weiss RA, Berk DR, Ahluwalia G. Phase 2 Randomized, Dose-Ranging Study of Oxymetazoline Cream for Treatment of Persistent Facial Erythema Associated With Rosacea. J Drugs Dermatol. 2018 Mar 1;17(3):308-316.
• Suggs AK, Macri A, Richmond H, Munavalli G, Friedman PM. Treatment of Erythematotelangiectatic Rosacea With Pulsed-Dye Laser and Oxymetazoline 1.0% Cream: A Retrospective Study. Lasers Surg Med. 2020 Jan;52(1):38-43. doi: 10.1002/lsm.23176. Epub 2019 Nov 10.
• Tan J, Liu H, Leyden JJ, Leoni MJ. Reliability of Clinician Erythema Assessment grading scale. J Am Acad Dermatol. 2014 Oct;71(4):760-3. doi: 10.1016/j.jaad.2014.05.044. Epub 2014 Jul 4.

• Responsible Party: Candela Corporation
• ClinicalTrials.gov Identifier: NCT04153188
• Other Study ID Numbers: DHF24671
• First Posted: Nov 6, 2019
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Candela Corporation: Erythema; Rosacea; Telangiectasia; pulsed dye laser; oxymetazoline hydrochloride 1% cream
• Additional relevant MeSH terms: Rosacea; Phenylephrine; Oxymetazoline

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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)

Arm/Group Title	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream	Oxymetazoline HCL 1% Cream
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	17	13
COMPLETED	14	11
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream	Oxymetazoline HCL 1% Cream	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	17	13	30
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	17 100%	13 100%	30 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44 (12)	46 (9)	45 (11)
Sex: Female, Male (Count of Participants)
Female	13 76.5%	10 76.9%	23 76.7%
Male	4 23.5%	3 23.1%	7 23.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 5.9%	1 7.7%	2 6.7%
Not Hispanic or Latino	16 94.1%	12 92.3%	28 93.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 7.7%	1 3.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	17 100%	12 92.3%	29 96.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	17 100%	13 100%	30 100%
Clinical Erythema Assessment (CEA) Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.2 (0.4)	3.2 (0.4)	3.2 (0.4)
Subject Self-Assessment (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.5 (0.5)	3.6 (0.5)	3.6 (0.5)

Outcome Measures

1. Primary Outcome

Title	Clinical Erythema Assessment (CEA) Score At 6-Month Post-Baseline
Description	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.
Time Frame	6-month post-baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream	Oxymetazoline HCL 1% Cream
Arm/Group Description	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.	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.
Measure Participants	14	11
Mean (Standard Deviation) [score on a scale]	1.6 (1.0)	2.4 (1.0)

2. Secondary Outcome

Title	Clinical Erythema Assessment (CEA) At the 1- ,2- and 3-Month Post-Baseline Visits
Description	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.
Time Frame	1- ,2- and 3-Month Post-Baseline Visits

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream	Oxymetazoline HCL 1% Cream
Arm/Group Description	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.	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.
Measure Participants	17	13
Clinical Erythema Assessment (CEA) At 1-Month Post-Baseline	2.6 (0.8)	2.6 (0.5)
Clinical Erythema Assessment (CEA) At 2-Month Post-Baseline	2.5 (0.6)	2.0 (0.6)
Clinical Erythema Assessment (CEA) At 3-Month Post-Baseline	2.0 (0.8)	2.3 (0.8)

3. Secondary Outcome

Title	Subject Self-Assessment (SSA) At the 1- ,2-, 3- and 6-Month Post-Baseline Visits
Description	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.
Time Frame	1-, 2-, 3- and 6-months post-baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream	Oxymetazoline HCL 1% Cream
Arm/Group Description	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.	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.
Measure Participants	17	13
Subject Self-Assessment (SSA) At the 1-Month Post Baseline	3.3 (0.8)	3.0 (0.6)
Subject Self-Assessment (SSA) At the 2-Month Post Baseline	2.7 (1.0)	2.3 (0.7)
Subject Self-Assessment (SSA) At the 3-Month Post Baseline	2.1 (1.1)	2.3 (0.7)
Subject Self-Assessment (SSA) At the 6-Month Post Baseline	1.4 (1.2)	2.2 (0.9)

4. Secondary Outcome

Title	Mean Investigator Assessment of Global Aesthetic Improvement (GAI) Grades At the 1-, 2-, 3- and 6-Month Post-Baseline
Description	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.
Time Frame	1-, 2-, 3- and 6-month post-baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream	Oxymetazoline HCL 1% Cream
Arm/Group Description	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.	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.
Measure Participants	17	13
Mean GAI Grade at 1-Months Post-Baseline Visit	2.5 (1.2)	2.7 (1.0)
Mean GAI Grade at 2-Months Post-Baseline Visit	2.3 (1.1)	1.4 (1.0)
Mean GAI Grade at 3-Months Post-Baseline Visit	1.7 (1.4)	2.5 (1.6)
Mean GAI Grade at 6-Months Post-Baseline Visit	1.2 (1.4)	2.5 (1.3)

5. Secondary Outcome

Title	Mean Subject Assessment of Global Aesthetic Improvement (GAI) Grades At the 1-, 2-, 3- and 6-Month Post-Baseline
Description	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.
Time Frame	1-, 2-, 3- and 6-month post-baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream	Oxymetazoline HCL 1% Cream
Arm/Group Description	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.	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.
Measure Participants	17	13
Mean GAI Grade at 1-Months Post-Baseline Visit	2.6 (1.0)	2.9 (1.0)
Mean GAI Grade at 2-Months Post-Baseline Visit	1.9 (0.8)	2.4 (0.7)
Mean GAI Grade at 3-Months Post-Baseline Visit	1.2 (1.0)	2.6 (0.9)
Mean GAI Grade at 6-Months Post-Baseline Visit	0.7 (0.9)	2.1 (0.9)

6. Secondary Outcome

Title	Measurement of Improvement in Vessel Size At the 1-, 2-, 3- and 6-Month Post-Baseline Visits
Description	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.
Time Frame	1-, 2-, 3- and 6-month post-baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream	Oxymetazoline HCL 1% Cream
Arm/Group Description	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.	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.
Measure Participants	17	13
Mean Vessel Size Improvement Grade at 1-Month Post-Baseline Visit	3.4 (0.9)	3.2 (0.7)
Mean Vessel Size Improvement Grade at 2-Month Post-Baseline Visit	2.4 (1)	2.7 (1.1)
Mean Vessel Size Improvement Grade at 3-Month Post-Baseline Visit	1.8 (1.1)	3.1 (1.2)
Mean Vessel Size Improvement Grade at 6-Month Post-Baseline Visit	1.6 (1.5)	3.1 (0.9)

7. Secondary Outcome

Title	Measurement of The Percentage of Subjects Reporting Satisfaction At the 6-Month Post-Baseline Visit
Description	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
Time Frame	6-month post-baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream	Oxymetazoline HCL 1% Cream
Arm/Group Description	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.	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.
Measure Participants	14	11
Count of Participants [Participants]	12 70.6%	7 53.8%

8. Secondary Outcome

Title	Measurement of Pain Associated With PDL Treatment
Description	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.
Time Frame	1-, 2- and 3-month post-baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream
Arm/Group Description	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.
Measure Participants	17
Measure PDL Treatments	47
Mean (Standard Deviation) [score on a scale]	4.5 (2.2)

Adverse Events

Time Frame	The period of time over which adverse event data were collected is from first visit until 6 month post baseline
Adverse Event Reporting Description	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).
Arm/Group Title	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream		Oxymetazoline HCL 1% Cream
Arm/Group Description	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.		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.
All Cause Mortality
	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream		Oxymetazoline HCL 1% Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/13 (0%)
Serious Adverse Events
	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream		Oxymetazoline HCL 1% Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	Pulsed Dye Laser & Oxymetazoline HCL 1% Cream		Oxymetazoline HCL 1% Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/17 (17.6%)		2/13 (15.4%)
Skin and subcutaneous tissue disorders
Dryness	1/17 (5.9%)	1	1/13 (7.7%)	1
Tingling	0/17 (0%)	0	1/13 (7.7%)	1
Blistering	2/17 (11.8%)	2	0/13 (0%)	0
Edema and Erythema	1/17 (5.9%)	1	0/13 (0%)	0
Papules	1/17 (5.9%)	1	0/13 (0%)	0

Limitations/Caveats

Small sample size for randomization

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.