Ultherapy® for the Treatment of Erythematotelangiectatic Rosacea

Clinician Erythema Assessment (CEA) and Patient Self-Assessment (PSA) scores, assessing
severity of erythema, will be obtained prior to study treatment to confirm subject
eligibility. Enrolled subjects will receive up to three dual-depth treatments to affected
areas of the midface (cheeks, chin, forehead, glabella and nose) each treatment provided
approximately 2 weeks apart. Groups A and B will receive low-density treatment, and Groups C
and D receive high-density treatment. Groups A and C will receive 2 treatments. Groups B and
D will receive 3 treatments. Protocol amended Sept 2014: Groups A and C will receive 1
treatment; Groups B and D will receive 2 treatments.

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.