Evaluation of the Safety and Efficacy of Ultherapy® for the  
Treatment of Signs and Symptoms of Erythematotelangiectatic Rosacea

Rosalyn George, MD1; Joel Schlessinger, MD2; Mark Lupin, MD3; David Amato, MD4; David McDaniel, MD5
1FAAD Wilmington Dermatology Center; Wilmington, NC; 2 FAAD, FAACS LovelySkin; Omaha, NE; 3 FAAD Cosmedica; Victoria, BC;  
4 All About Faces; Hummelstown, PA; 5 FAAD Laser and Cosmetic Center; Virginia Beach, VA

• It is hypothesized that creation of focal lesions in the dermis and sub-dermis may affect 
the symptoms of erythematotelangiectatic rosacea by inducing coagulation in superficial 
blood vessels and reducing blood flow in the skin

BACKGROUND AND OBJECTIVE

• The study enrolled 88 subjects (79 female and 9 male) with a mean age of 49.8 (range, 21-65 
years). Fitzpatrick Skin Types were I (5.7%, II (40.9%) and III (53.4%). 

• Pre-treatment medication was limited to 800mg Ibuprofen taken at least 60 minutes prior 
to treatment. 

• Treatment groups are summarized in Table 1.
• Assessments (baseline & follow-up visits):

 - Standardized photographs
 - 5-point Clinical Erythema Assessment (CEA) Scale
 - Colorimeter assessment

• Figures 1-3 illustrate the treatment maps used for each transducer depth and density.

    Table 1. Treatment groups. All subjects were to receive 2 treatments. 

Group Subjects, n Treatments, n Treatment Density

A 20 1 Low (15 lines/square)

B* 22 2 Low (15 lines/square)

C 24 1 High (30 lines/square)

D* 22 2 High (30 lines/square)

“*Due to a treatment protocol modification, only subjects in Groups B & D recieved 2 treatments (14 +/- 4 days apart).

METHODS

  Adverse Event
# Subjects Average Duration of  

Resolved AEs (Days)N=88 (%)

Bruising 39 44% 10.2

Soreness/Tenderness 38 43% 12.9

Parasthesia (numbness) 9 10% 12.5

Raised Area of Edema/Welts 15 17% 9.0

Erythema (redness) 33 35% 4.8

Other (oily skin, worsening of rosacea, 
aphthous ulcer)

4 4.5% 2.0/31.0/10

Figure 4. Treatment Success Based on CEA Scores. CEA improvement (≥1-grade improvement) 
was greatest in Group C at Day 90 (91%) and at Day 365 (96%), Group A at Day 180 (95%).

Figure 5. Treatment Success Based on PSA Scores. PSA improvement (≥1-grade improvement) 
was greatest in Group D at Day 90 (74%), Group D at Day 180 (75%), and Group B at Day 365 (76%).

Figure 6. Improved Colorimeter Readings. Colorimeter improvement (reduction in red-green 
spectrum vs baseline only) was greatest in Group A at Day 90 (75%), Group A at Day 180 (74%), and 
Group C at Day 365 (86%). 

Figure 7: Mean Pain Scores, First Treatment. Mean pain scores were generally consistent 
between treatment groups; for subjects in Group B &D, the second treatment pain scores were 
similar to the first treatment.

Table 1. Adverse Events. No serious adverse events were reported.

RESULTS

Disclosure: This study and poster were sponsored by Merz North America, Inc.

Ultherapy® is a registered trademark of Ulthera, Inc.

• Results suggest Ultherapy may be 
efficacious for treatment of signs and 
symptoms of erythematotelangiectatic 
rosacea.

• Study data suggest that high density 
Ultherapy treatment is superior to low 
density treatments or to superficial 
treatments.

CONCLUSIONS

Figure 8. Sample Patient Before (Left) and At Day 90 (Right)

%
 o

f S
ub

je
ct

s 
w

it
h

1-
g

ra
d

e 
Im

p
ro

ve
m

en
t

Treatment Group

Timepoint

Group A Group B Group C Group D
0

10
20
30
40
50
60
70
80
90

100

Day 90 (N=84)

Day 180 (N=84)

Day 365 (N=81)75
.0

%

91
.3

%

84
.2

%94
.7

%

94
.4

%

77
.3

%

85
.0

%95
.5

%

90
.9

%

85
.7

%

82
.6

%

80
.0

%

%
 o

f S
ub

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ct

s 
Sh

ow
in

g
Im

p
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ve
m

en
t

Treatment Group

Timepoint

Group A Group B Group C Group D
0

10
20
30
40
50
60
70
80
90

100

Day 90 (N=84)

Day 180 (N=84)

Day 365 (N=81)

60
.0

% 69
.6

%

73
.7

%

73
.7

%

66
.7

%

72
.7

%

60
.0

%7
2.

7%

72
.7

%

76
.2

%

65
.2

%

75
.0

%

P
ai

n 
Sc

or
e

Transducers

Treatment Group

4-4.5mm

7-3.0mm

10-1.5mm

0
1
2
3
4
5
6
7
8
9

10

Group A Group B Group C Group D

6.5 6.7 6.4

3.9
4.9

5.9 5.55.6

3.9
4.6 4.4 4.4

%
 o

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ub

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ct

s 
Sh

ow
in

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Im

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t

Treatment Group

Timepoint

Group A Group B Group C Group D
0

10
20
30
40
50
60
70
80
90

100

75
.0

%

56
.5

%

72
.2

%

73
.7

%

72
.2

%

63
.6

% 8
0

.0
%

86
.4

%

68
.2

%

71
.4

%

69
.9

%

70
.0

%

Day 90 (N=84)

Day 180 (N=84)

Day 365 (N=81)

Figure 2. Treatment map for 7 MHz/3.0 mm transducer.

Figure 3. Treatment map for 10 MHz/1.5 mm transducer.

Figure 1. Treatment map for 4 MHz/4.5 mm transducer. 


	FC17PosterMerzGeorgeEvaluationSafetyUltherapy.pdf