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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
3 monthly Vbeam® Prima PDL treatments with a 3-day washout of topical Oxymetazoline HCL 1% cream before each treatment.
Daily application of Oxymetazoline HCL 1% cream for the 6-month study.
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, United States
Dermatology & Laser Surgery Center
Houston, Texas, United States
Clinical Erythema Assessment (CEA) Score At 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.
Time frame: 6-month post-baseline
Clinical Erythema Assessment (CEA) At the 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.
Time frame: 1- ,2- and 3-Month Post-Baseline Visits
Subject Self-Assessment (SSA) At the 1- ,2-, 3- and 6-Month Post-Baseline Visits
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
Mean Investigator Assessment of Global Aesthetic Improvement (GAI) Grades At the 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.
Time frame: 1-, 2-, 3- and 6-month post-baseline
Mean Subject Assessment of Global Aesthetic Improvement (GAI) Grades At the 1-, 2-, 3- and 6-Month Post-Baseline
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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
Measurement of Improvement in Vessel Size At the 1-, 2-, 3- and 6-Month Post-Baseline Visits
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
Measurement of The Percentage of Subjects Reporting Satisfaction At the 6-Month Post-Baseline Visit
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
Measurement of Pain Associated With PDL Treatment
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