Clinical trial NCT04153188: Pulsed Dye Laser Treatment and Oxymetazoline Hydrochloride (HCL) 1% Cream for Erythematotelangiectatic Rosacea
Official title: Pilot Study to Evaluate Vbeam® Prima Pulsed Dye Laser (PDL) Treatment and RHOFADE® (Oxymetazoline HCL, 1% Cream) for Erythematotelangiectatic Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erythematotelangiectatic Rosacea
Keywords: Erythema
Rosacea
Telangiectasia
pulsed dye laser
oxymetazoline hydrochloride 1% cream
Lead sponsor: Candela Corporation
Sponsor class: INDUSTRY
First posted: 2019-11-06
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Erythema Assessment (CEA) Score At 6-Month Post-Baseline
timeFrame: 6-month post-baseline
Secondary outcomes:
measure: Clinical Erythema Assessment (CEA) At the 1- ,2- and 3-Month Post-Baseline Visits
timeFrame: 1- ,2- and 3-Month Post-Baseline Visits
measure: Subject Self-Assessment (SSA) At the 1- ,2-, 3- and 6-Month Post-Baseline Visits
timeFrame: 1-, 2-, 3- and 6-months post-baseline
measure: Mean Investigator Assessment of Global Aesthetic Improvement (GAI) Grades At the 1-, 2-, 3- and 6-Month Post-Baseline
timeFrame: 1-, 2-, 3- and 6-month post-baseline
measure: Mean Subject Assessment of Global Aesthetic Improvement (GAI) Grades At the 1-, 2-, 3- and 6-Month Post-Baseline
timeFrame: 1-, 2-, 3- and 6-month post-baseline
measure: Measurement of Improvement in Vessel Size At the 1-, 2-, 3- and 6-Month Post-Baseline Visits
timeFrame: 1-, 2-, 3- and 6-month post-baseline
measure: Measurement of The Percentage of Subjects Reporting Satisfaction At the 6-Month Post-Baseline Visit
timeFrame: 6-month post-baseline
measure: Measurement of Pain Associated With PDL Treatment
timeFrame: 1-, 2- and 3-month post-baseline
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Dermatology, Laser & Vein Specialists of the Carolinas
state: North Carolina
city: Houston
country: United States
facility: Dermatology & Laser Surgery Center
state: Texas
Study officials:
affiliation: Candela Corporation
name: Konika P Schallen, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.