Blinded, Bilateral Hair Removal Study Comparing the ... Study Comparing the Alexandrite Laser with...

Blinded, Bilateral Hair Removal Study Comparing the

Alexandrite Laser with MPX Mode

6 Subject Subset

Baseline through 6 Mo Follow Up

Investigator: E. Bernstein

Created by: Jennifer Franklin 7.29.2010

Objectives/Study Design

Objectives • Validate mathematical model of

single and multiple wavelength fluence for equivalent heating at 2 mm depth

• Evaluate pain, erythema, edema and satisfaction through patient and physician evaluations

• Evaluate therapeutic outcome

through photography and hair counts

• Compare efficacy of Alexandrite vs. Alex/YAG, YAG/Alex combinations

Study Design • Subjects presented with

unwanted hair on the axilla received 4 TX, 4-6 week intervals

• Subjects were divided into two groups:

• Group 1: R=Alex/YAG L=Alex • Group 2: R=YAG/Alex L=Alex

• Follow ups were conducted at 2 months 6 months post last treatment

Alex/Nd:YAG Fluence Combination Model

Mathematical Model Validation: • Correlate efficacy of single wavelength vs. MPX Based on equivalent

heating in the hair follicle optical absorption of melanin at 755 and 1064nm • Model accounts for the light absorption of the two wavelengths in the

epidermis and considers the case of light to moderately pigmented adult skin.

• Hair removal efficacy as a therapeutic outcome is correlated to the peak

temperature rise in the targeted structures – hair follicle bulb and bulge.

• In conclusion, this study validated hair reduction between single wavelength vs. MPX and established baseline parameters for which therapeutic fluence can be determined

Parameters/Subject Population

Demographics:

Caucasian 6

Females 6

Minimum Age 34

Maximum Age 50

Average Age 42

TX Fluence

(J)

Pulse Duration

(ms)

Cool Setting (1-10)

Alex/YAG 15/17 10/10 8

Alex 20 20 8

YAG/Alex 17/15 10/10 8

• 15 mm spot size used

•The fluences were kept consistent for each treatment type

•The same treatment parameters were used at subsequent treatments

Fitzpatrick Score

V0%

I0%

IV11%

II11%

III11%

Treatment Pain

•The YAG/Alex treatment was slightly more painful as compared to Alex and Alex/YAG treatments

•The treatment pain between Alex and Alex/YAG treatments was similar

Group 1 Subjects: 5,7,8


Treatment Average

Pain Treatment Average

Pain

Alex/YAG 2.5 YAG/Alex 3.8

Alex 2.4 Alex 2.2

Average Treatment Pain Tx1-Tx4 Scale: 0-5

Extrusion

• Extrusion scores did not differ greatly per treatment type

Average Extrusion Tx1-Tx4

Scale: 1 - 4



Treatment Average

Extrusion Treatment Average

Extrusion


Alex 1.8 Alex 1.7

Perifollicular Edema

•Perifollicular Edema scores did not differ greatly per treatment type

Average Perifollicular Edema Tx1-Tx4

Scale: 1 - 4



Treatment

Average Perifollicular

Edema Treatment

Average Perifollicular

Edema


Alex 1.4 Alex 1.3

Patient Satisfaction Results- 6 months post last treatment

Average Score: Texture: 4 (0-4 Scale) Appearance: 3 (0-4 Scale) Hair Reduction: 3 (0-4 Scale) Would Recommend: • 100% of the subjects would recommend to a friend (6 of 6)

Evaluation Scale

Physician Satisfaction Results- 6 months post last treatment

Average Score: Texture: 4 (0-4 Scale) Appearance: 4 (0-4 Scale) Hair Reduction: 4 (0-4 Scale) • The Physician gave the highest rating for

improvement in texture, appearance and hair reduction

Evaluation Scale

Subject LD- Group 1

Alex

Alex/YAG

Baseline Pre Tx(3) 2 Months Post 4 Tx 6 Months Post 4 Tx

Subject LD- Group 1

d= 21.747 hairs/cm2 d= 5.602 hairs/cm2 d= 3.718 hairs/cm2 d= 1.171 hairs/cm2


Alex

Alex/YAG


Subject LD- Group 1

Alex/YAG

Alex

Baseline 6 Months Post 4 Tx

6 Months Post 4 Tx Baseline

d= 14.668 hairs/cm2

d= 13.293 hairs/cm2

d= 1.171 hairs/cm2

d= 0.662 hairs/cm2

d= 21.747 hairs/cm2 d= 1.171 hairs/cm2

d= 18.284 hairs/cm2 d= 1.222 hairs/cm2

Subject LD- Group 1

Alex/YAG

Alex

Subject JT- Group 2

Alex

YAG/Alex


Subject JT- Group 2

d= 22.053 hairs/cm2 d= 4.686 hairs/cm2 d= 3.310 hairs/cm2


d= 0.713 hairs/cm2

Alex

YAG/Alex Baseline Pre Tx(3) 2 Months Post 4 Tx 6 Months Post 4 Tx

Subject JT- Group 2

YAG/Alex

Alex

Baseline 6 Months Post 4 Tx

Subject JT- Group 2

d= 19.659 hairs/cm2

d= 22.053 hairs/cm2

Baseline 6 Months Post 4 Tx YAG/Alex

Alex

d= 0.917 hairs/cm2

d= 0.713 hairs/cm2

Hair Clearance Through 6 Months Post 4 Treatments

Group 1

75%

79%76%

82% 82%80%

85%

92%89%

91% 91%

77%

50%

60%

70%

80%

90%

100%

Alex Alex/YAG Alex YAG/Alex

Post 2 Tx2 Months Post 4 Tx6 Months Post 4 Tx

Hai

r Cle

aran

ce

Group 2

No Statistical Significant Difference P>.05 No Statistical Significant Difference P>.05

Clinical Comparison of Results

Average Hair Clearance Results • 1 month post 2 treatments, there was a 77% reduction in hair.

• by 755nm, 77%;

• by 755nm/1064nm, 77%;

• by 1064nm/755nm, 76%.

• 2 months post 4 treatments there was an 82% reduction in hair.

• by 755nm, 81%;

• by 755nm/1064nm, 82%;

• by 1064nm/755nm, 79%.

• 6 months post 4 treatments there was a 90% reduction in hair:

• by 755nm, 91%;

• by 755nm/1064nm, 82%;

• by 1064nm/755nm, 79%.


• Elite MPX Evaluations • The Alex/YAG Treatment slightly more painful

• All treatments experienced similar results in Extrusion, Perifollicular Edema and Hair Clearance

• 100% of subject would recommend treatment to a friend


• Alexandrite laser (Cynosure 510k data) • 76% reduction post 15 months, post 3-5 TX

• Nd:YAG (Alster/Tanzi, Derm Surg, 2004) • 58%-69% reduction post 1 month post 3 TX

• 41% -53% reduction post 6 months post 3TX

• Nd:YAG (S. Kilmer white paper) • 43% reduction post 1month, post 1 TX

• 27% reduction post 3 months, post 1 TX

Industry standard to determine clearance or

reduction of hair follicles is:

6 months post last Tx

Blinded, Bilateral Hair Removal Study Comparing the ... Study Comparing the Alexandrite Laser with...

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