Pulsed Dye Laser Treatment and Oxymetazoline Hydrochloride (HCL) 1% Cream for Erythematotelangiectatic Rosacea
Condition: Erythematotelangiectatic Rosacea
MeSH terms: Rosacea
Intervention: The Vbeam® Prima System; Oxymetazoline HCL 1% Cream
Intervention description: 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.
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
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).
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Erythema; Rosacea; Telangiectasia; pulsed dye laser; oxymetazoline hydrochloride 1% cream

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.
    

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.