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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
Group 2 Subjects: 14,16,20
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
Group 1 Subjects: 5,7,8
Group 2 Subjects: 14,16,20
Treatment Average
Extrusion Treatment Average
Extrusion
Alex/YAG 1.9 YAG/Alex 1.6
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
Group 1 Subjects: 5,7,8
Group 2 Subjects: 14,16,20
Treatment
Average Perifollicular
Edema Treatment
Average Perifollicular
Edema
Alex/YAG 1.3 YAG/Alex 1.3
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
d= 21.747 hairs/cm2 d= 5.602 hairs/cm2 d= 3.718 hairs/cm2 d= 1.171 hairs/cm2
d= 18.284 hairs/cm2 d= 4.736 hairs/cm2 d= 2.241 hairs/cm2 d= 1.222 hairs/cm2
Alex
Alex/YAG
Baseline Pre Tx(3) 2 Months Post 4 Tx 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
d= 22.053 hairs/cm2 d= 4.686 hairs/cm2 d= 3.310 hairs/cm2
d= 19.659 hairs/cm2 d= 4.991 hairs/cm2 d= 1.681 hairs/cm2 d= 0.917 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
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%.
Clinical Comparison of Results
• 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
Clinical Comparison of Results
• 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