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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsed Dye Laser & Oxymetazoline HCL 1% Cream | Experimental | 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. |
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| Oxymetazoline HCL 1% Cream | Active Comparator | Once daily application of pea-sized amount to face of Oxymetazoline HCL 1% Cream during the 6-month study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Vbeam® Prima System | Device | 3 monthly Vbeam® Prima PDL treatments with a 3-day washout of topical Oxymetazoline HCL 1% cream before each treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6-month post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Konika P Schallen, MD | Candela Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology, Laser & Vein Specialists of the Carolinas | Charlotte | North Carolina | 28207 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24999270 | Background | 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. | |
| 29537449 | Background | 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. |
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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)
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6-month post-baseline |
|
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dryness | Skin and subcutaneous tissue disorders | Systematic Assessment | Mild dryness from oxymetazoline usage on the cheeks and forehead reported at the 1 month post baseline visit - 1 experienced at the first week of usage - both adverse events recovered without intervention before the 1 month post baseline visit. |
Small sample size for randomization
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Candela Corporation | +1 904 6549629 | konikap@candelamedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 11, 2018 | Feb 23, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| D004890 | Erythema |
| D013684 | Telangiectasis |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D010109 | Oxymetazoline |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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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).
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| Oxymetazoline HCL 1% Cream | Drug | Daily application of Oxymetazoline HCL 1% cream for the 6-month study. |
|
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| 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. | 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. | 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 | 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. | 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. | 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 | 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. | 1-, 2- and 3-month post-baseline |
| Dermatology & Laser Surgery Center |
| Houston |
| Texas |
| 77030 |
| United States |
| 29635699 | Background | 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. |
| 31709571 | Background | 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. |
| 34233378 | Result | Sodha P, Suggs A, Munavalli GS, Friedman PM. A Randomized Controlled Pilot Study: Combined 595-nm Pulsed Dye Laser Treatment and Oxymetazoline Hydrochloride Topical Cream Superior to Oxymetazoline Hydrochloride Cream for Erythematotelangiectatic Rosacea. Lasers Surg Med. 2021 Dec;53(10):1307-1315. doi: 10.1002/lsm.23439. Epub 2021 Jul 7. |
| Subject withdrew due to rebound erythema when Oxymetazoline wore off |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Clinical Erythema Assessment (CEA) Score | Investigator Clinical Erythema Assessment (CEA): A five category scale ranging from 0 [clear skin with no signs of erythema] to 4 [severe erythema; fiery redness] | Mean | Standard Deviation | units on a scale |
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| Subject Self-Assessment | Subject Self-Assessment (SSA): A five category scale ranging from 0 [Clear of unwanted redness] to 4 [Completely unacceptable redness]. | Mean | Standard Deviation | units on a scale |
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| OG001 | 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. |
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| Secondary | 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. | Arm 1- Two subjects dropped before 2-month post-baseline visit. Arm 2- One subject dropped before 2-month post-baseline visit. | Posted | Mean | Standard Deviation | score on a scale | 1- ,2- and 3-Month Post-Baseline Visits |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 1-, 2-, 3- and 6-months post-baseline |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 1-, 2-, 3- and 6-month post-baseline |
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| Secondary | Mean Subject Assessment of Global Aesthetic Improvement (GAI) Grades At the 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 1-, 2-, 3- and 6-month post-baseline |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 1-, 2-, 3- and 6-month post-baseline |
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| Secondary | 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 | 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. | Posted | Count of Participants | Participants | 6-month post-baseline |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 1-, 2- and 3-month post-baseline | PDL Treatments | PDL Treatments |
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| 0 |
| 17 |
| 0 |
| 17 |
| 3 |
| 17 |
| EG001 | 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. | 0 | 13 | 0 | 13 | 2 | 13 |
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| Tingling | Skin and subcutaneous tissue disorders | Systematic Assessment | Subject experienced mild tingling sensation on the cheeks after applying oxymetazoline, but improved after continued use. |
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| Blistering | Skin and subcutaneous tissue disorders | Systematic Assessment | Mild blistering that appeared on the skin after first PDL treatment. Both cases resolved spontaneously before the 1-week post treatment visit. |
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| Edema and Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment | Mild case of prolong edema and erythema on the cheeks and forehead after the first PDL treatment that has recovered without intervention after the 1-week follow up |
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| Papules | Skin and subcutaneous tissue disorders | Systematic Assessment | Papules on the cheeks and forehead within the first month of oxymetazoline cream, which improved after several weeks of applying topical SOOLANTRA ® (ivermectin) cream, 1%. |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Clinical Erythema Assessment (CEA) At 2-Month Post-Baseline |
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| Clinical Erythema Assessment (CEA) At 3-Month Post-Baseline |
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| Subject Self-Assessment (SSA) At the 2-Month Post Baseline |
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| Subject Self-Assessment (SSA) At the 3-Month Post Baseline |
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| Subject Self-Assessment (SSA) At the 6-Month Post Baseline |
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| Mean GAI Grade at 2-Months Post-Baseline Visit |
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| Mean GAI Grade at 3-Months Post-Baseline Visit |
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| Mean GAI Grade at 6-Months Post-Baseline Visit |
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| Mean GAI Grade at 2-Months Post-Baseline Visit |
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| Mean GAI Grade at 3-Months Post-Baseline Visit |
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| Mean GAI Grade at 6-Months Post-Baseline Visit |
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| Mean Vessel Size Improvement Grade at 2-Month Post-Baseline Visit |
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| Mean Vessel Size Improvement Grade at 3-Month Post-Baseline Visit |
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| Mean Vessel Size Improvement Grade at 6-Month Post-Baseline Visit |
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