Pantene AgeDefy

Alan J. Bauman, M.D – Medical Director
Bauman Medical Group, P.A. Boca Raton FL
Consulting Division
HAIR THICKENING CLINICAL TRIAL
rev 3.21.2013

BIO / OVERVIEW
•  Alan J. Bauman, M.D.
•  New York Medical College
•  Beth Israel Medical Center – General Surgery
•  Mt. Sinai Medical Center – General Surgery
•  Eastwood Medical Center – Hair Transplantation
•  Diplomate, American Board of Hair Restoration Surgery
•  Recommended, American Hair Loss Association
•  Member, International Society of Hair Restoration Surgery

ALAN J. BAUMAN, M.D.
“IN THE NEWS”
•  CNN, MSNBC, FOX News, NY Times, WSJ, Men’s Health, Women’s Health
•  W, Vogue, Elle, Cosmo, Redbook, Harpers Bazaar, Newsweek, USA Today
•  CBS Early Show, NBC Today Show, ABC Good Morning America, Extra!, Access Hollywood
•  Telemundo, Il Terreno (Milan), Plastica y Estetica (Sao Paolo), China Daily (Bejing)

BAUMAN MEDICAL GROUP – BOCA RATON
•  Est 1997 – Hair Restoration for Men and Women
•  Currently: 1000 new patients/yr - 50:50 male/female
•  Medical Evaluations, Diagnostics, Genetic Testing, Research
•  Multi-Therapy Regimen
•  ~250 hair transplants / year
•  250,000 tabs of finasteride / year
•  >12,000 ml/month of compounded minoxidil
•  Hundreds of LaserCaps / year
•  >3000 HairCheck Trichometry measurements
•  Hair care for thinning hair
•  Nutrition & more…

OVERVIEW
•  Hair Thinning / Hair Loss
•  Psychological Impact
•  Clinical Trial Overview
•  Enrollment / Evaluation
•  Attrition
•  Multimedia
•  Video & Photos
•  Results/Data
•  Conclusions

BACKGROUND INFO :
THINNING HAIR
•  Hair Loss / Thinning Hair
•  ~40 million American women
•  Loss of Volume, Increased Shedding
•  Decrease in Scalp Coverage
•  Do not typically ‘go bald,’ but severe hair loss can occur
•  Primarily: Androgenetic Alopecia (Hereditary Hair Loss)
•  Other Factors: nutrition, medications, illness, stress, hormone imbalance, surgery,
hair breakage

FEMALE HAIR LOSS
“Ludwig-Savin” Scale

PSYCHOLOGICAL IMPACT
•  Underappreciated
•  MODERATE: styling limitations, feel
unattractive, low self esteem, poor self-
image, low self-confidence
•  SEVERE: depression, humiliation, lead
to isolation, avoidance of social
situations

HAIR FOLLICLE ANATOMY
Normal
Miniaturized

THERAPY OPTIONS
•  Medical – Pharmaceuticals, Laser Therapy, Nutrition
•  Improve hair follicle function
•  prevent & reverse miniaturization
•  Surgical – Hair Transplantation
•  Redistribute hair follicles to improve density
•  Cosmetic – Hair Products & Hair Care
•  prevent hair fiber breakage
•  improve hair fiber performance

•  ~100 Women with thinning hair, ages 35+
•  Caucasian, African-American, Latino
•  12 week product trial – one application daily; 6+12 wk f/u
•  “blank bottle” - Participants did not know the brand
•  Radio, TV, referrals, social media & PR recruitment
•  Self-Evaluation/Feedback forms
•  HairCheck (HMI cross-section hair bundle trichometry)
•  HairScan (single strand sequential hair diameter scanning)
•  Global Photos
•  Results / Case Studies
•  MD’s Recommendations / Comments

HAIRCHECK™ TRICHOMETRY
•  Cross-Section Hair Bundle Trichometry
•  Dr. Bernard Cohen’s patented Trichometer
•  Sensitive and Specific measurement tool
•  Repeatable & Accurate without tattoos
•  Measures changes in hair thickness (and density)
•  Hair Mass Index = HMI
•  Normal Occipital HMI = 65-130+, average = ~70

INT’L SOCIETY OF HAIR RESTORATION SURGERY
ANNUAL SCIENTIFIC MEETING - 2012 BAHAMAS

HAIRCHECK ON ABC NEWS

SCALP ANATOMY
Frontal Area
Vertex/Crown Area
Occipital Area

HAIRSCAN™ HAIRSHAFT MORPHOLOGY
•  Single Strand Sequential Hair Diameter Scanning ~40 measurements/cm

HAIR MASS INDEX AT BASELINE
•  This indicates we enrolled patients
with significant thinning hair
problems
•  To calculate % hair loss at baseline,
we compare frontal and vertex HMI’s
to occipital HMI…
0
20
40
60
80
100
120
140
160
0 5 10 15 20 25
HairMassindex(HMI)
Tab
Hair Mass Index at Enrollment
Frontal
Crown/Vertex

HAIR LOSS PERCENT CALCULATION
(Occipital HMI – Frontal HMI)
---------------------------------------- X 100 = % Frontal Hair Loss
(Occipital HMI)
(Occipital HMI – Vertex HMI)
---------------------------------------- X 100 = % Vertex Hair Loss
(Occipital HMI)

ENROLLMENT n=112
% HAIR LOSS AT
BASELINE
•  Occipital HMI ave = 76
•  Frontal HMI ave = 56.8
% frontal loss = 24%
•  Vertex HMI ave = 69.1
% vertex loss = 9%

ENROLLMENT
Trial participants were asked to
•  Not add hair treatments/procedures
•  Not change their hair color/style
•  Use the product once per day
•  Answer feedback and self-assessment
questionnaires
•  Visit at six and twelve week intervals
for measurements, feedback and
photos

FINAL REPORT
•  March 15, 2011 – Product Arrival
•  April 5, 2011 – 1st patient Enrolled
•  As of October 31, 2012…
•  456 inquires
•  112 enrolled
•  94 completed 12 wks w/ feedback
•  72 completed 12 wks + measurements/photos
•  18 dropped out, 5 sited “product issues”

ATTRITION / ADVERSE EFFECTS
18 patients have dropped out from the trial
•  Product Issues n=5 (4.4%)
•  “Dried out the hair”
•  “Hair harder to comb, causing more hair fall”
•  “Scalp itch”
•  “Build up”
•  Personal Reasons or Unclassified n=13

RESULTS SUMMARY
WEEK 12 (n = 72)
WEEK

Frontal
HMI

Vertex
HMI

0
54.1
65.5

6
57.8
69.8

12
58.3
72.1

50
55
60
65
70
75
0 6 12
HairMassIndex(HMI)
Weeks
HMI Changes Over Time
Frontal
Vertex
8-10%
improvement
in Hair Mass

RESULTS SUMMARY
CHANGES IN AVERAGE FRONTAL HMI (n=72)
WEEK

Frontal
HMI

%Change
from
baseline

0
54.1
-

6
57.8
6.9%

12
58.3
7.8%

50
51
52
53
54
55
56
57
58
59
0 6 12
HairMassIndex(HMI)
Weeks

RESULTS SUMMARY
CHANGES IN AVERAGE VERTEX HMI (n=72)
WEEK
Vertex HMI

% Change
From
Baseline

0
65.5
-

6
69.8
6.6%

12
72.1
10.1%

62
64
66
68
70
72
74
0 6 12
HairMassIndex(HMI)
Weeks

BEFORE & AFTER
PHOTOS

CASE #37: FRANCO, LUZ
WEEK

Frontal
HMI

Vertex
HMI

0
38
73

6
42
90

12
37
84

30
40
50
60
70
80
90
100
0 6 12HairMassIndex(HMI)
Weeks
Frontal
Vertex

Baseline 12 Weeks

Baseline 12 Weeks
“My hair has more volume. It makes my hair look thicker.”

CASE #8: ACKNER, ROBBYN

CASE #8: ACKNER, ROBBYN (CON’T)
“My hair is easier to style. It feels smoother, softer, easier to manage.”

CASE #21: MARTINEZ, CAROL
WEEK

Frontal
HMI

Vertex
HMI

0
34
48

6
60
64

12
61
72

30
35
40
45
50
55
60
65
70
75
0 6 12
HairMassIndex(HMI)
Weeks
Frontal
Vertex

Baseline 12 Weeks

Baseline 12 Weeks
“I can’t see my scalp as much. I went from constantly seeing my scalp to not noticing it.”

Baseline 12 Weeks
“My hair has thickened with this product. …[it] makes me feel better about myself and in
control of my hair loss. I have seen dramatic results!”

CASE #32: AUGUST, HEDY
WEEK

Frontal
HMI

Vertex
HMI

0
36
51

6
33
60

12
39
58

30
35
40
45
50
55
60
65
0 6 12
HairMassIndex(HMI)
Weeks
Frontal
Vertex

CASE #32: AUGUST, HEDY
“Easy to use, smells good. My hair is easier to manage.”

CASE #32: AUGUST, HEDY (CON’T)

CASE #22: BERMAN, TERRI
WEEK

Frontal
HMI

Vertex
HMI

0
33
56

6
50
58

12
43
74

30
35
40
45
50
55
60
65
70
75
80
0 6 12
HairMassIndex(HMI)
Weeks
Frontal
Vertex

CASE #22: BERMAN, TERRI
Baseline 12 Weeks
“My hair looks thicker. The product does not leave my hair greasy or weighed down.”

CASE #32: BERMAN, TERRI (CON’T)
Baseline 12 Weeks
“My hair feels thicker and seems to be stronger and healthier.”

CASE #34: WAGY, RUTH
Baseline 12 Weeks
“Seems to make my hair feel a little stronger.”

CASE #34: WAGY, RUTH
Bauman Medical Group - Hair Mass Index (HairNumber) Tracking Sheet
Hair Thickening Clinical Trial
For more information on Hair Mass Index (HMI) or "HairNumber" and how to maintain or enhance your HMI, visit
http:/./wwwbaumanmedical.com or call 561-394-0024
Patient Name: Wagy, Ruth Date of Birth: 12/25/62
Exam Date
Occipital Tab
#33(Control)
Vertex Tab
#20
%Loss vs.
Control
Frontal Tab #
9
%Loss vs.
Control
Other Tab # Notes
5/23/11 51 46 25 51%
7/5/11 51 34 33% 26 49%
8/23/11 51 40 22% 22 57%
NOTES:
Hair Mass Index Log
15
25
35
45
55
65
75
85
Hair Mass Index
Occipital Tab #33(Control)
Vertex Tab #20
Frontal Tab # 9
Other Tab #
“Easy to use.”

CASE #25: STEVENS, GERRI
Baseline 12 Weeks
“Smells good, dries quick. Makes my hair feel thicker.”

Baseline 12 Weeks

Baseline 12 Weeks
“I don’t see my scalp as much.”

CASE #20: SHARKEY, BARBARA
Baseline 12 Weeks
“Smells great. Easy to use.”

Bauman Medical Group - Hair Mass Index (HairNumber) Tracking Sheet
Hair Thickening Clinical Trial
Patient Name: Sharkey, Barbara Date of Birth: 2/6/1954 PATIENT ID # 20
Exam Date
Occipital Tab
#34(Control)
Vertex Tab
#21
%Loss vs.
Control
Frontal
Tab # 8
%Loss vs.
Control
Other Tab
#
Notes Techs
4/27/2011 33 15 55% 21 36% FR/CD
6/15/2011 33 30 9% 33 0% FR/CD
10/3/2011 33 34 -3% 40 -21% FR/CD
NOTES:
Hair Mass Index Log
10
20
30
40
50
Hair Mass Index
Occipital Tab #34(Control)
Vertex Tab #21
Frontal Tab # 8
Other Tab #
For more information on Hair Mass Index (HMI) or "HairNumber" and how to maintain or enhance your HMI, visit
http:/./wwwbaumanmedical.com or call 561-394-0024
Baseline 12 Weeks

Baseline 12 Weeks

SURVEY / SELF ASSESSMENT

SELF-ASSESSMENT / RESULTS n=87
•  SATISFACTION SURVEY at 12 weeks
•  [1=best, 5=worst], n=87
•  Made Hair Feel Thicker = 1.68
83% (4 out of 5) participants said their hair felt thicker.

RESULTS: HAIR THICKER?
83% (4 out of 5) participants said their hair felt thicker!
0
5
10
15
20
25
30
35
40
Much Better Somewhat Bettter About the Same Somewhat Worse Much Worse
Thickening Performance Compared to Usual Product

RESULTS: EASE OF USE?
99% of participants said it was “easy to use!”
0
10
20
30
40
50
60
Extremely Easy Very Easy Somewhat Easy Not Very Easy Not At All Easy
Ease of Use

RESULTS: NEW & DIFFERENT?
100% of participants said it was ‘new and different!’
0
5
10
15
20
25
30
35
Extremely New/Diff Very New/Diff Somewhat New/Diff Slightly New/Diff Not At All New/Diff
New & Different?

RESULTS: OVERALL RATING?
99% of participants rated it “good” to “excellent!”
0
5
10
15
20
25
30
35
40
45
Excellent Very Good Good Fair Poor
Overall Rating

SELF-ASSESSMENT / RESULTS n=87
•  SATISFACTION SURVEY at 12 weeks
•  [1=best, 5=worst], n=87
•  Like the Product = 1.74
•  New & Different = 1.79
•  Made Hair Feel Thicker = 1.68
•  Ease of Use = 1.36
•  Overall rating of product = 1.65

ADVERSE EFFECTS
•  No scalp irritation
•  Some complained of dryness and difficult combing… (small # however)
•  No complaints of build-up or residue from any participants at 6 or 12 wks.
•  LIMITATIONS:
•  Women with severe hair loss may not notice the effects
•  Does not replace hair fibers
•  Does not address the chronic and progressive nature of hereditary hair loss
•  May act as a crutch or method to delay medical intervention

FEEDBACK (USAGE)
•  Quick to apply
•  Easy to use
•  Dries Quickly
•  Smells Great, Good, Nice
•  Nice Container
•  Nice Pump
•  Not sticky, oily, or greasy
•  Does not spoil hairstyle
•  Dissolves quickly
•  Cool, Invigorating, tingles
•  Don’t like the alcohol smell
•  Dries my hair out somewhat
•  Sometimes hair gets frizzy
•  Hard to comb

FEEDBACK (HAIR EFFECTS)
•  Does not weigh down the hair
•  Hair feels thicker, more manageable
•  Hair looks better, feels stronger yet softer
•  Easier to style
•  Hair looks fuller, wavier.
•  Hair grew. Less breakage.
•  Hair appears to be thicker
•  More volume, more body
•  Can’t see scalp as much
•  I went from constantly seeing my scalp to not noticing it!

FEEDBACK (VALUE)
•  Improves my morale and mood
•  I have seen dramatic results
•  Love the way my hair behaves
•  Makes me feel confident
•  Would pay $15-20/bottle, $30/bottle, $49.99/bottle…
•  This product makes me feel better about myself and in control of my hair loss
•  I can still get it, right?

CONCLUSIONS
•  Hair Thickener provided a positive benefit for most users in the trial
•  Even if HMI did not increase, benefits were noted by most users
•  Very few participants disliked the product – most liked the benefits
•  Hair Thickener added another dimension of “hair management” to our current offerings
•  Ease of use
•  Improvement in cosmetic condition of hair / manageability
•  Improvement in scalp coverage
•  4 out of 5 users reported that their hair felt thicker
•  Provided psychological boost to many participants

“THANK YOU”
P&G AND BMG STAFF !
•  Hilary Roman – Clinical Trial Coordinator
•  Liz Ashe – Patient Services / Recruitment
•  Linda Fiorito – Patient Services / Scheduling
•  Carol Dennis – HairCheck Technician
•  Felipe Reynoso – HairCheck Technician
•  Patricia Condor – HairCheck Technician
•  Brianne Stokes – HairCheck Technician
•  Gyna Bosse – Patient Services

Alan J. Bauman, M.D.
Bauman Medical Group
Boca Raton, FL USA
doctorb@baumanmedical.com
www.baumanmedical.com
www.linkedin/in/alanjbauman
www.twitter.com/DrAlanBauman
www.facebook.com/alanjbauman

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