pantene agedefy

67
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

Upload: bambooagency

Post on 19-Jun-2015

286 views

Category:

Business


0 download

DESCRIPTION

AgeDefy

TRANSCRIPT

  • 1. 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

2. HAIR THICKENING CLINICAL TRIAL 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 3. HAIR THICKENING CLINICAL TRIAL ALAN J. BAUMAN, M.D. IN THE NEWS CNN, MSNBC, FOX News, NY Times, WSJ, Mens Health, Womens 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) 4. HAIR THICKENING CLINICAL TRIAL 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 5. HAIR THICKENING CLINICAL TRIAL OVERVIEW Hair Thinning / Hair Loss Psychological Impact Clinical Trial Overview Enrollment / Evaluation Attrition Multimedia Video & Photos Results/Data Conclusions 6. HAIR THICKENING CLINICAL TRIAL 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 7. HAIR THICKENING CLINICAL TRIAL FEMALE HAIR LOSS Ludwig-Savin Scale 8. HAIR THICKENING CLINICAL TRIAL 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 9. HAIR THICKENING CLINICAL TRIAL 10. HAIR THICKENING CLINICAL TRIAL HAIR FOLLICLE ANATOMY Normal Miniaturized 11. HAIR THICKENING CLINICAL TRIAL 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 12. HAIR THICKENING CLINICAL TRIAL HAIR THICKENING CLINICAL TRIAL ~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 MDs Recommendations / Comments 13. HAIR THICKENING CLINICAL TRIAL HAIRCHECK TRICHOMETRY Cross-Section Hair Bundle Trichometry Dr. Bernard Cohens 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 14. HAIR THICKENING CLINICAL TRIAL INTL SOCIETY OF HAIR RESTORATION SURGERY ANNUAL SCIENTIFIC MEETING - 2012 BAHAMAS 15. HAIR THICKENING CLINICAL TRIAL HAIRCHECK ON ABC NEWS 16. HAIR THICKENING CLINICAL TRIAL SCALP ANATOMY Frontal Area Vertex/Crown Area Occipital Area 17. HAIR THICKENING CLINICAL TRIAL HAIRSCAN HAIRSHAFT MORPHOLOGY Single Strand Sequential Hair Diameter Scanning ~40 measurements/cm 18. HAIR THICKENING CLINICAL TRIAL 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 HMIs 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 19. HAIR THICKENING CLINICAL TRIAL 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) 20. HAIR THICKENING CLINICAL TRIAL 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% 21. HAIR THICKENING CLINICAL TRIAL 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 22. HAIR THICKENING CLINICAL TRIAL 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 23. HAIR THICKENING CLINICAL TRIAL 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 24. HAIR THICKENING CLINICAL TRIAL 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 25. HAIR THICKENING CLINICAL TRIAL 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 26. HAIR THICKENING CLINICAL TRIAL 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 27. HAIR THICKENING CLINICAL TRIAL BEFORE & AFTER PHOTOS 28. HAIR THICKENING CLINICAL TRIAL 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 HMI Changes Over Time Frontal Vertex 29. HAIR THICKENING CLINICAL TRIAL CASE #37: FRANCO, LUZ Baseline 12 Weeks 30. HAIR THICKENING CLINICAL TRIAL CASE #37: FRANCO, LUZ Baseline 12 Weeks My hair has more volume. It makes my hair look thicker. 31. HAIR THICKENING CLINICAL TRIAL CASE #8: ACKNER, ROBBYN 32. HAIR THICKENING CLINICAL TRIAL CASE #8: ACKNER, ROBBYN (CONT) My hair is easier to style. It feels smoother, softer, easier to manage. 33. HAIR THICKENING CLINICAL TRIAL 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 HMI Changes Over Time Frontal Vertex 34. HAIR THICKENING CLINICAL TRIAL CASE #21: MARTINEZ, CAROL Baseline 12 Weeks 35. HAIR THICKENING CLINICAL TRIAL CASE #21: MARTINEZ, CAROL Baseline 12 Weeks I cant see my scalp as much. I went from constantly seeing my scalp to not noticing it. 36. HAIR THICKENING CLINICAL TRIAL CASE #21: MARTINEZ, CAROL 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! 37. HAIR THICKENING CLINICAL TRIAL 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 HMI Changes Over Time Frontal Vertex 38. HAIR THICKENING CLINICAL TRIAL CASE #32: AUGUST, HEDY Easy to use, smells good. My hair is easier to manage. 39. HAIR THICKENING CLINICAL TRIAL CASE #32: AUGUST, HEDY (CONT) 40. HAIR THICKENING CLINICAL TRIAL 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 HMI Changes Over Time Frontal Vertex 41. HAIR THICKENING CLINICAL TRIAL CASE #22: BERMAN, TERRI Baseline 12 Weeks My hair looks thicker. The product does not leave my hair greasy or weighed down. 42. HAIR THICKENING CLINICAL TRIAL CASE #32: BERMAN, TERRI (CONT) Baseline 12 Weeks My hair feels thicker and seems to be stronger and healthier. 43. HAIR THICKENING CLINICAL TRIAL CASE #34: WAGY, RUTH Baseline 12 Weeks Seems to make my hair feel a little stronger. 44. HAIR THICKENING CLINICAL TRIAL 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. 45. HAIR THICKENING CLINICAL TRIAL CASE #25: STEVENS, GERRI Baseline 12 Weeks Smells good, dries quick. Makes my hair feel thicker. 46. HAIR THICKENING CLINICAL TRIAL CASE #25: STEVENS, GERRI Baseline 12 Weeks 47. HAIR THICKENING CLINICAL TRIAL CASE #25: STEVENS, GERRI Baseline 12 Weeks I dont see my scalp as much. 48. HAIR THICKENING CLINICAL TRIAL CASE #20: SHARKEY, BARBARA Baseline 12 Weeks Smells great. Easy to use. 49. HAIR THICKENING CLINICAL TRIAL CASE #20: SHARKEY, BARBARA 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 50. HAIR THICKENING CLINICAL TRIAL CASE #20: SHARKEY, BARBARA Baseline 12 Weeks 51. HAIR THICKENING CLINICAL TRIAL CASE #20: SHARKEY, BARBARA Baseline 12 Weeks 52. HAIR THICKENING CLINICAL TRIAL CASE #20: SHARKEY, BARBARA Baseline 12 Weeks 53. HAIR THICKENING CLINICAL TRIAL SURVEY / SELF ASSESSMENT 54. HAIR THICKENING CLINICAL TRIAL 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. 55. HAIR THICKENING CLINICAL TRIAL 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 56. HAIR THICKENING CLINICAL TRIAL 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 57. HAIR THICKENING CLINICAL TRIAL 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? 58. HAIR THICKENING CLINICAL TRIAL 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 59. HAIR THICKENING CLINICAL TRIAL 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 60. HAIR THICKENING CLINICAL TRIAL 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 61. HAIR THICKENING CLINICAL TRIAL 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 Dont like the alcohol smell Dries my hair out somewhat Sometimes hair gets frizzy Hard to comb 62. HAIR THICKENING CLINICAL TRIAL 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 Cant see scalp as much I went from constantly seeing my scalp to not noticing it! 63. HAIR THICKENING CLINICAL TRIAL 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? 64. HAIR THICKENING CLINICAL TRIAL 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 65. HAIR THICKENING CLINICAL TRIAL 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 66. HAIR THICKENING CLINICAL TRIAL Alan J. Bauman, M.D. Bauman Medical Group Boca Raton, FL USA [email protected] www.baumanmedical.com www.linkedin/in/alanjbauman www.twitter.com/DrAlanBauman www.facebook.com/alanjbauman