Clinical trial: Ultherapy® for the Treatment of Erythematotelangiectatic Rosacea (NCT02144181)

Eligibility criteria:
Inclusion Criteria:

          1. Male or female, age 18 to 65 years.

          2. Subject in good health.

          3. Clinical diagnosis of Erythematotelangiectatic Rosacea.

          4. Understands and accepts the obligation not to undergo any other elective procedures,
             i.e., laser and IPL, in the areas to be treated through the follow-up period.

          5. A Clinician Erythema Assessment (CEA) score of greater than or equal to 3 at Screening
             and at Baseline/Day 0 (prior to study treatment commencement).

          6. A Patient Self-Assessment (PSA) of erythema score of greater than or equal to 2 at
             Screening and at Baseline/Day 0 (prior to study treatment commencement).

          7. Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other NSAID
             prior to each study treatment and chronic use during the entire post-treatment study
             period. Washout period, if chronic user, for 4 weeks prior to the first treatment.
             After all study treatments are completed, limited acute NSAID use is allowed. A
             maximum of 2-3 doses, in the 2 weeks prior to study follow-up visits is allowed, if
             needed.

          8. Willingness to continue using current skin care and topical treatment regimen during
             the entire study period (1 year).

          9. Willingness and ability to comply with protocol requirements, including returning for
             follow-up visits and abstaining from exclusionary procedures for the duration of the
             study, unless deemed medically necessary.

         10. Subjects of childbearing potential must have a negative urine pregnancy test result
             and must not be lactating at Visit 1 and be willing and able to use an acceptable
             method of birth control .

         11. Absence of physical or psychological conditions unacceptable to the investigator.

         12. Willingness and ability to provide written consent for study-required photography and
             adherence to photography procedures (i.e., removal of jewelry and makeup).

         13. Willingness and ability to provide written informed consent and HIPAA authorization
             prior to performance of any study-related procedure.

        Exclusion Criteria:

          1. Presence of an active systemic disease that may affect wound healing.

          2. More than 5 prominent telangiectases (>0.2mm in width, the width of a thick human
             hair, images will be provided) in the area(s) to be treated, with the exception of the
             lateral sides of the nose.

          3. Particular forms of rosacea (papulopustular, phymatous, ocular Rosacea, rosacea
             conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin)
             or other concomitant facial dermatoses that are similar to rosacea such as peri-oral
             dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, or acute
             lupus erythematosus.

          4. Presence of three (3) or more facial inflammatory lesions (papules or pustules) of
             rosacea.

          5. Current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates,
             sedatives, systemic anesthetics, or alpha agonists.

          6. Intense flushing to a few triggers, such as post-menopausal hot flashes or particular
             food, versus both intense and less intense flushing to several common triggers.

          7. Less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac
             glycosides, beta blockers or other antihypertensive agents which have vasodilation as
             the MOA (e.g., the calcium channel blockers, such as nifedipine).

          8. Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic
             hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal
             or hepatic impairment, scleroderma, Sjögren's syndrome, or clinically diagnosed
             depression (unless on a stable treatment regimen.)

          9. History of post-inflammatory hyperpigmentation.

         10. Severe solar elastosis.

         11. Significant scarring that would interfere with assessing results in areas to be
             treated.

         12. Open wounds or lesions in the area(s) to be treated.

         13. Acne.

         14. Active implants (e.g., pacemakers or defibrillators), or metallic implants in the
             treatment areas (dental implants not included.)

         15. Inability to understand the protocol or to give informed consent.

         16. Microdermabrasion or glycolic acid peels to the treatment areas within four weeks
             prior to study participation or during the study.

         17. Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick
             sebaceous skin in the area(s) to be treated.

         18. History of chronic drug or alcohol abuse.

         19. History of autoimmune disease.

         20. History of Bell's Palsy or epilepsy

         21. History of diabetes.

         22. Concurrent therapy that, in the investigator's opinion, would interfere with the
             evaluation of the safety or efficacy of the study device.

         23. Subjects who anticipate the need for inpatient surgery or overnight hospitalization
             during the study.

         24. Subjects who, in the investigator's opinion, have a history of poor cooperation,
             noncompliance with medical treatment, or unreliability.

         25. Concurrent enrollment, or participated within the past 30 days, in any study involving
             the use of investigational devices or drugs.

         26. Current smoker or history of smoking in the last five years.

         27. Current user of any nicotine-containing products, e.g., e-cigarettes, Nicorette gum,
             nicotine patches, etc.

         28. History of the following cosmetic treatments in the areas to be treated:

               1. Skin tightening procedure within the past year;

               2. Injectable filler of any type within the past:

             i. 12 months for Hyaluronic acid fillers (e.g.,Restylane)

             ii. 12 months for Ca Hydroxyapatite fillers (e.g., Radiesse)

             iii. 24 months for Long-lasting Hyaluronic acid (Juvéderm Voluma) and Poly-L-Lactic
             acid fillers (e.g., Sculptra)

             iv. Ever for permanent fillers (e.g., Silicone, ArteFill)

             c. Neurotoxins within the past three months;

             d. Ablative resurfacing laser treatment;

             e. Nonablative, rejuvenative laser or light treatment within the past six months;

             f. Surgical dermabrasion or deep facial peels;

         29. History of using Accutane or other systemic retinoids within the past six months;

         30. Topical retinoids within the past two weeks;

         31. Antiplatelet agents / Anticoagulants (Coumadin, Heparin, Plavix);

         32. Chronic use of non-steroidal anti-inflammatories (naproxen, ibuprofen, etc.) within
             the past 4 weeks.

         33. Psychiatric drugs that in the investigators opinion would impair the subject from
             understanding the protocol requirements, understanding and signing the informed
             consent, or affect their ability to accurately complete QOL and subjective improvement
             assessments.

         34. Use of Mirvaso (topical brimonidine tartrate) within the previous two weeks.

         35. Use of systemic corticosteroid or immunosuppressive drugs.

         36. Use of antipruritics, including antihistamines, within 24 hours of study visits.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21.

Patient description (patient's own words): I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21.

Does the patient match the trial criteria? 1