Erythematotelangiectatic Rosacea
Conditions
Keywords
Erythema, Rosacea, Telangiectasia, pulsed dye laser, oxymetazoline hydrochloride 1% cream
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.
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.
Interventions
DEVICEThe Vbeam® Prima System
3 monthly Vbeam® Prima PDL treatments with a 3-day washout of topical Oxymetazoline HCL 1% cream before each treatment.
DRUGOxymetazoline HCL 1% Cream
Daily application of Oxymetazoline HCL 1% cream for the 6-month study.
Sponsors
Candela Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
| 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. |
Countries
United States
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 details
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)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| 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. | 13 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Subject withdrew due to rebound erythema when Oxymetazoline wore off | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Pulsed Dye Laser & Oxymetazoline HCL 1% Cream | Oxymetazoline HCL 1% Cream | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 13 Participants | 30 Participants |
| Age, Continuous | 44 years STANDARD_DEVIATION 12 | 46 years STANDARD_DEVIATION 9 | 45 years STANDARD_DEVIATION 11 |
| Clinical Erythema Assessment (CEA) Score | 3.2 units on a scale STANDARD_DEVIATION 0.4 | 3.2 units on a scale STANDARD_DEVIATION 0.4 | 3.2 units on a scale STANDARD_DEVIATION 0.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 12 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 12 Participants | 29 Participants |
| Region of Enrollment United States | 17 participants | 13 participants | 30 participants |
| Sex: Female, Male Female | 13 Participants | 10 Participants | 23 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
| Subject Self-Assessment | 3.5 units on a scale STANDARD_DEVIATION 0.5 | 3.6 units on a scale STANDARD_DEVIATION 0.5 | 3.6 units on a scale STANDARD_DEVIATION 0.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 13 |
| other Total, other adverse events | 3 / 17 | 2 / 13 |
| serious Total, serious adverse events | 0 / 17 | 0 / 13 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulsed Dye Laser & Oxymetazoline HCL 1% Cream | Clinical Erythema Assessment (CEA) Score At 6-Month Post-Baseline | 1.6 score on a scale | Standard Deviation 1 |
| Oxymetazoline HCL 1% Cream | Clinical Erythema Assessment (CEA) Score At 6-Month Post-Baseline | 2.4 score on a scale | Standard Deviation 1 |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pulsed Dye Laser & Oxymetazoline HCL 1% Cream | 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 0.8 |
| Pulsed Dye Laser & Oxymetazoline HCL 1% Cream | Clinical Erythema Assessment (CEA) At the 1- ,2- and 3-Month Post-Baseline Visits | Clinical Erythema Assessment (CEA) At 2-Month Post-Baseline | 2.5 score on a scale | Standard Deviation 0.6 |
| Pulsed Dye Laser & Oxymetazoline HCL 1% Cream | Clinical Erythema Assessment (CEA) At the 1- ,2- and 3-Month Post-Baseline Visits | Clinical Erythema Assessment (CEA) At 3-Month Post-Baseline | 2.0 score on a scale | Standard Deviation 0.8 |
| Oxymetazoline HCL 1% Cream | 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 |
| Oxymetazoline HCL 1% Cream | 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 |
| Oxymetazoline HCL 1% Cream | 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 |
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.
Time frame: 1-, 2-, 3- and 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pulsed Dye Laser & Oxymetazoline HCL 1% Cream | 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 | 2.5 score on a scale | Standard Deviation 1.2 |
| Pulsed Dye Laser & Oxymetazoline HCL 1% Cream | 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 | 2.3 score on a scale | Standard Deviation 1.1 |
| Pulsed Dye Laser & Oxymetazoline HCL 1% Cream | 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 | 1.7 score on a scale | Standard Deviation 1.4 |
| Pulsed Dye Laser & Oxymetazoline HCL 1% Cream | 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 | 1.2 score on a scale | Standard Deviation 1.4 |
| Oxymetazoline HCL 1% Cream | 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 |
| Oxymetazoline HCL 1% Cream | 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 |
| Oxymetazoline HCL 1% Cream | 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 |
| Oxymetazoline HCL 1% Cream | 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 |
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.
Time frame: 1-, 2-, 3- and 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pulsed Dye Laser & Oxymetazoline HCL 1% Cream | 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 | 2.6 units on a scale | Standard Deviation 1 |
| Pulsed Dye Laser & Oxymetazoline HCL 1% Cream | 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 | 1.9 units on a scale | Standard Deviation 0.8 |
| Pulsed Dye Laser & Oxymetazoline HCL 1% Cream | 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 | 1.2 units on a scale | Standard Deviation 1 |
| Pulsed Dye Laser & Oxymetazoline HCL 1% Cream | 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 | 0.7 units on a scale | Standard Deviation 0.9 |
| Oxymetazoline HCL 1% Cream | 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 |
| Oxymetazoline HCL 1% Cream | 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 |
| Oxymetazoline HCL 1% Cream | 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 |
| Oxymetazoline HCL 1% Cream | 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 |
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.
Time frame: 1-, 2-, 3- and 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pulsed Dye Laser & Oxymetazoline HCL 1% Cream | 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 | 3.4 score on a scale | Standard Deviation 0.9 |
| Pulsed Dye Laser & Oxymetazoline HCL 1% Cream | 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 | 2.4 score on a scale | Standard Deviation 1 |
| Pulsed Dye Laser & Oxymetazoline HCL 1% Cream | 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 | 1.8 score on a scale | Standard Deviation 1.1 |
| Pulsed Dye Laser & Oxymetazoline HCL 1% Cream | 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 | 1.6 score on a scale | Standard Deviation 1.5 |
| Oxymetazoline HCL 1% Cream | 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 |
| Oxymetazoline HCL 1% Cream | 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 |
| Oxymetazoline HCL 1% Cream | 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 |
| Oxymetazoline HCL 1% Cream | 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 |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulsed Dye Laser & Oxymetazoline HCL 1% Cream | Measurement of Pain Associated With PDL Treatment | 4.5 score on a scale | Standard Deviation 2.2 |
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
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pulsed Dye Laser & Oxymetazoline HCL 1% Cream | Measurement of The Percentage of Subjects Reporting Satisfaction At the 6-Month Post-Baseline Visit | 12 Participants |
| Oxymetazoline HCL 1% Cream | Measurement of The Percentage of Subjects Reporting Satisfaction At the 6-Month Post-Baseline Visit | 7 Participants |
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.
Time frame: 1-, 2-, 3- and 6-months 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pulsed Dye Laser & Oxymetazoline HCL 1% Cream | 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 | 3.3 score on a scale | Standard Deviation 0.8 |
| Pulsed Dye Laser & Oxymetazoline HCL 1% Cream | 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 | 2.7 score on a scale | Standard Deviation 1 |
| Pulsed Dye Laser & Oxymetazoline HCL 1% Cream | 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 | 2.1 score on a scale | Standard Deviation 1.1 |
| Pulsed Dye Laser & Oxymetazoline HCL 1% Cream | 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 | 1.4 score on a scale | Standard Deviation 1.2 |
| Oxymetazoline HCL 1% Cream | 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 |
| Oxymetazoline HCL 1% Cream | 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 |
| Oxymetazoline HCL 1% Cream | 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 |
| Oxymetazoline HCL 1% Cream | 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 |