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  • 1. A Novel Topical Transdermal Delivery System Mark S. Nestor, M.D., Ph.D. Pankaj Modi, Ph.D, M.D.
  • 2.
    • Dr. Nestor is a consultant for Transdermal Corp. Data presented was provided to Dr. Nestor by Transdermal Corp.
    • Dr. Modi is president and Founder of Transdermal Corp
    • The material presented related to the Topical Toxin Formulations (cosmetic and Hyperhidrosis indications) are NOT approved by the FDA and are under the clinical investigation outside the US at present
    • The Topical Hyaluronic Acid/Collagen cosmetic cream and Acne treatments are not subject to FDA approval and are available for marketing and distribution in North America
    Disclosure
  • 3. Topical Drug Delivery
    • The skin is a formidable barrier against environmental assaults as well as topical drug delivery
    • A variety of active compounds have significant activity in the skin, subcutaneous tissue or muscle but cannot adequately permeate the intact skin
    • Diseases such as acne, psoriasis, rosacea, and melasma as well as cutaneous aesthetic enhancement could dramatically benefit from our ability to better transport active compounds to target tissue
    • Ionic Nano Particle Technology (InParT) is a novel and unique delivery system that can be utilized to assist the transport of a variety of active compounds to target sites in the skin and beyond
  • 4. InParT Drug Delivery System Ionic Nano Particle Technology I
    • Novel , commercially viable trans dermal non-invasive drug delivery technology that enables delivery and absorption of active compounds through the stratum corneum and throughout the skin and sub cutaneous tissue without any cutaneous toxicity
  • 5. InParT Drug Delivery System Ionic Nano Particle Technology II
    • Nano particles are made from combinations of micelles (surfactants and protein solubilizers), coated with lipid molecules
    • Nano paticles size; less than 1-10 nano meters smaller than the skin pores
    • Nano Particles Physically entraps active without any changes in the chemical composition
    • Stabilizes the actives: shelf stable at room temperature for extended period of time without refrigeration)
    • Uses all FDA approved ingredients
  • 6. InParT Drug Delivery System Ionic Nano Particle Technology III
    • INParT technology is highly adaptable to most high molecular weight drugs, proteins, peptides and insoluble hydrophobic molecules
    • Capable of delivering more than one therapeutic agent at a time
    • Offers high market value by featuring maximum functionality at minimum system complexity and cost
    • The technology is easily scalable to any size without any complex new equipments need (no capital expenditure, commercially viable)
  • 7. SEM-Photograph- 250x SEM-Photograph- 1000x
  • 8. InParT Drug Delivery System Clinical Investigation
    • Topical Lidocaine (Innovatec, Inc)
    • Topical Hyaluronic Acid
    • Acne
      • Benzoyl Peroxide (BP)
    • Topical Botulinum Neurotoxin Type A (BoNTA)
      • Rhytids
    • Hyperhidrosis
  • 9. NTL4: The Next Generation Topical Anesthetic Optimized 4% Topical Lidocaine in a Unique Nano Technology Delivery System Results of Clinical Trials Comparing NTL4 to LMX4 Protocols N ° 10025 10025.1 Center for Clinical and Cosmetic Research (CCCR), Aventura, Florida Mark S. Nestor, M.D., Ph.D.
  • 10.
    • NTL4 is an experimental topical Anesthetic owned by Innovatech, Inc.
    • LMX4 is a commercially available topical anesthetic owned by Ferndale Laboratories
    • Clinical studies results in this presentation are preliminary
    • Studies preformed at CCCR in Aventura, Florida and Manhattan Beach, California. Mark S. Nestor, M.D., Ph.D., Principle Investigator, Glynis Ablon, M.D., Co Investigator
    • Funding provided by a Research Grant from Innovatech, Inc.
    Disclosure
  • 11.
    • The successful reduction of pain is one of the primary goals of medical care.
    • The medical management of pain encompasses injury, medical conditions and surgical procedures
    • The use of topical anesthetics (TA) is an important part of the management of pain both by physicians and consumers
    • In a recent study TA were prescribed or used 3.8 million times by physicians over a 5 year study interval and yet accounted for only a small fraction of the overall consumer use of TA
    • At the present time Dermatologists represent only a small fraction of physicians that use of TA, primarily using TA for minor surgical and cosmetic procedures
    Introduction Yentzer BA et al.: Utilization of Topical Anesthetics By Dermatologists in the US. Cosmetic Derm 22, 238 2009.
  • 12.
    • TA are classified as RX, OTC or pharmacy compounded medications and contain a variety of ingredients from benzocaine to lidocaine to cocaine. Worldwide market estimated at over $5 billion in sales.
    • OTC Lidocaine (LMX4) is the most commonly used and prescribed TA by physicians
    • Important characteristics of TA include efficacy, onset and safety
    • The ideal TA would have the ability to provide a significant anesthetic effect shortly after application (5 – 10 minutes), have an excellent safety profile and be available to patients and physicians OTC
    • TA efficacy and onset limited by difficulty in drugs penetrating the skin barrier
    • Optimized drug delivery system can dramatically improve TA effectiveness, and onset and allow the use of safe, OTC strength compounds
    Topical Anesthetics Yentzer BA et al.: Utilization of Topical Anesthetics By Dermatologists in the US. Cosmetic Derm 22, 238 2009.
  • 13. Topical Drug Delivery
    • The skin is a formidable barrier against environmental assaults as well as topical drug delivery
    • A variety of active compounds have significant activity in the skin, subcutaneous tissue or muscle but cannot adequately permeate the intact skin
    • The use of topical anesthetics is limited based on the difficulty that Lidocaine and other topical anesthetics to penetrate the skin
    • Additionally, diseases such as acne, psoriasis, rosacea, and melasma as well as cutaneous aesthetic enhancement could dramatically benefit from our ability to better transport active compounds to target tissue
    • Ionic Nano Particle Technology (InParT) is a novel and unique delivery system that can be utilized to assist the transport topical anesthetics and of a variety of active compounds to target sites in the skin and beyond
  • 14.
    • NTL4 is a unique 4% Lidocaine TA based on the INParT drug delivery system
    • The INParT drug delivery system allows for rapid and efficient transfer of the Lidocaine through the stratum cornenum, epidermis and dermis to the sensory nerves
    • 4% lidocaine is ideal because of it OTC FDA indication
    • Clinical trails were conducted to test efficacy and safety of NTL4 as a TA in patients receiving Restylane injections in the NLF. The trails utilized LMX4 (the market leader in commercially available 4% lidocaine) in the contra lateral NLF as an active control
    • The initial trial investigated the efficacy and safety comparing a 20 minute application of both products
    • The second trial accessed early onset efficacy at 5, 10, and 15 minute application of both products
    NTL4
  • 15. CCCR Protocol 10025
    • Double Blind, Randomized, Split-Face Study to Evaluate the Efficacy, Safety and Subject Satisfaction of Pain Management Utilizing NTL4 (Topical 4% Lidocaine in a Novel Nano Technology Delivery System) vs. LMX 4 (4% Lidocaine cream) During and After Restylane® Dermal Filler Injections for the Correction of Nasolabial Folds
  • 16. Study Design: Protocol 10025
    • Two-center, randomized, split-face, double-blind pilot trial to evaluate the effectiveness of a test product NTL4 versus L-M-X4® topical anesthetic immediately post, one and three hours after Restylane® injections in the NLF.
    • 2-day study
    • 30 patients total for 2 sites randomized left and right to NLT4 or LMX4, respectively, randomly applied (20 second massage) to each NLF for 20 minutes and removed
    • Investigator and patient assessments completed at screening /injection immediately upon injection, at 1 hour and 3 hours at visit 1
    • Follow-up assessments completed at Visit 2 (next day)
    • AE and concomitant medication review / update at each visit
    AE, adverse event.
  • 17. Results Summary: Protocol 10025
    • Subjective mean VAS scores for the 30 subjects indicated significantly less pain upon injection (p=0.04), one hour after injection (p< 0.01) and trend at 3 hours (p=0.06) favoring NTL4 over LMX4
    • Subjective assessment of level of pain indicated clear but not significant trend favoring NTL4 over LMX4
    • Subjects preference of topical anesthetic significantly favored NTL4 over LMX4 (p=0.002)
    • Blinded investigator assessment of pain indicated significantly less pain on the NTL4 treated vs. LMX4 treated side (p=0.002)
    • Blinded investigators overall satisfaction (adequate anesthesia) significantly favored NTL4 over LMX4 (p< 0.001)
  • 18. Results Summary: Protocol 10025
    • AE’s were all classified as minor and included tenderness, bruising and edema all of which were considered to be related to the Restylane injections
    • There were no apparent differences in the injection related AE’s for either NTL4 or LMX4
  • 19. CCCR Protocol 10025.1
    • Double Blind, Randomized, Split-Face Study to Evaluate the Onset of Topical 4% Lidocaine in a Novel Nano Technology Delivery System vs. LMX 4 (4% Lidocaine cream) During and After Restylane® Dermal Filler Injections for the Correction of Nasolabial Folds
  • 20. Study Design: Protocol 10025.1
    • Two-center, randomized, split-face, double-blind pilot trial to evaluate the effectiveness of a test product NTL4 versus L-M-X4® topical anesthetic immediately post, one and three hours after Restylane® injections in the NLF.
    • 2-day study
    • 20 patients total for 2 sites randomized left and right to NLT4 or LMX4, respectively
    • 3 group randomization for onset of effectiveness: 15, 10 and 5 minute duration of topical cream prior to injection
    • Investigator and patient assessments completed at screening/injection Immediately upon injection, at 1 hour and 3 hours at Visit 1
    • Follow-up assessments completed at Visit 2 (next day)
    • AE and concomitant medication review / update at each visit
    AE, adverse event.
  • 21. Results Summary I: Protocol 10025.1
    • Subjective mean VAS scores for the 20 subjects (combined early onset) indicated significantly less pain upon injection (p<0.001), with trends at one hour after injection and trend at 3 hours favoring NTL4 over LMX4. VAS immediate injection score lower for NTL4 in early onset trial vs original 20 minute trial (1.57 vs 1.99) but higher for the LMX4 (3.86 vs 3.02) .Mean Individual onset groups: significantly less pain favoring NTL4 over LMX4 for 15 minute and 5 minute incubations (p=0.04) with trend favoring NTL4 at 10 minutes. Trends favoring NTL4 at one and three hours in all groups
  • 22. Results Summary II: Protocol 10025.1
    • Subjective assessment for the 20 subjects (combined early onset) of level of pain indicated significant less pain on NTL4 over LMX4 (p<0.001). Individual onset groups: significantly less pain favoring NTL4 over LMX4 for 15 minute and 5 minute incubations (p=0.01, p=0.006) with trend favoring NTL4 at 10 minutes.
    • Subjects preference of topical anesthetic for the 20 subjects (combined early onset) significantly favored NTL4 over LMX4 (p=0.002). Individual onset groups: significant preference favoring NTL4 over LMX4 for 15 minute 10 minute and 5 minute incubations (p=0.001, p= 0.05, p=0.02)
    • Blinded investigator assessment of pain for the 20 subjects (combined early onset) indicated significantly less pain on the NTL4 treated vs. LMX4 treated side (p=0.001) Individual onset groups: significantly less pain favoring NTL4 over LMX4 for 15 minute (p=0.02) with trends favoring NTL4 for the 10 minute and 5 minute incubations
  • 23. Results Summary III: Protocol 10025.1
    • Blinded investigators overall satisfaction (adequate anesthesia) for the 20 subjects (combined early onset) significantly favored NTL4 over LMX4 (p<0.001). Individual onset groups: significant preference favoring NTL4 over LMX4 for 15 minute 10 minute and 5 minute incubations (p= 0.05)
    • AE’s were all classified as minor and included tenderness, bruising and edema all of which were considered to be related to the Restylane injections. One patient (15 minute) demonstrated erythema and edema lasting 4 days, initially bilateral and then unilateral (NTL4 side). Cleared with topical cortisone. Thought to be reaction to Lidocaine.
  • 24. Efficacy Results: Subjective VAS Early Onset (5 Minutes) (N=6) N=6 N=6 N=6 p=0.045 p=0.309 p=0.643 d=0.61 (Large) d=0.27 (Small) X Axis: Time After Injection Y Axis: VAS Scale
  • 25. Subjective Level of Pain Early Onset (5 Minutes) (N=6) P=0.079 LMX4 NTL4 Product_Randomization 4 3 2 1 0 Count Moderate Pain Mild Pain Minimal Pain No Pain Subject_Level_of_Pain Bar Chart
  • 26. Subject Satisfaction Data: Overall Preference Early Onset (5 Minutes) (N=6) P=0.02 Preference Rates: NTL4 = 83% (5/6) LMX4 = 16% (1/6) No Preference = 0% (0/8)
  • 27. Blinded Investigator’s Evaluation of Pain Early Onset (5 Minutes) (N=6) P=0.076 LMX4 NTL4 Product_Randomization 4 3 2 1 0 Count Mild Pain Minimal Pain No Pain Subject_Level_of_Pain Bar Chart
  • 28. VAS Comparison: Onset Immediate Post Injection N=30 N=6 N=8 N=6 p=0.044 p=0.004 p=0.068 p=0.045 d=0.98 (Large) X Axis: Duration of Application Y Axis: VAS Scale
  • 29. Results Combined Trials
  • 30. Results Summary Combined Trials
    • All evaluations categories both subjective and investigator assessed for combined trials (n=50) demonstrated significantly less pain and significantly favored the NTL4 vs. LMX4 (p<0.01 or better)
    • VAS scores for NTL4 similar and independent of incubation time (20, 15, 10, 5 minutes) at immediate, one hour and three hours
  • 31. Discussion I
    • Trails compared subjective and blinded investigator assessment pain, as well as preference following Restylane injections in the NLF comparing a novel 4 % lidocaine in nano technology delivery system (NTL4) to commercially available LMX4
    • Results indicate that NTL4 is significantly superior to LMX4 according to blinded subjective bilateral comparisons and blinded investigator observations. Results consistent at one hour and three hours after injection and is related to both half life of lidocaine and decreased initial pain
    • NTL4 appears to have significant efficiency with extremely short incubation (15,10 and 5 minutes) after 30 second massage application. Variations in significance of individual onset groups secondary to small n in each group. Differences between initial and early onset study (apparent enhanced effect of NTL4 may be due to 30 vs 20 second application massage)
  • 32. Discussion II
    • AE’s mild and appear associated with injections except for one subject. Erythema and edema started bilaterally and continued in NTL4 treatment side. Probable cause is lidocaine topical sensitivity.
    • NTL4 show significant promise as a next generation topical anesthetic having significantly enhanced effect and early onset ability
    • Nano technology allows for enhanced rapid penetration of lidocaine through the stratum corneum, epidermis and dermis to the sensory nerves
    • 4% lidocaine allows for OTC status: both as a physician used (dispensed) and general consumer use
    • Short incubation times (early onset) will be very attractive to dermatologists and pediatricians
    • Commercial launch of OTC within months (just need stability testing)
  • 33. Topical Hyaluronic Acid (HA)
  • 34. InParT Drug Delivery System Topical Hyaluronic Acid (HA)
    • HA crosslinked or non crosslinked difficult to adequately penetrate the stratum corneum
    • If adequate penetration can be achieved topical cross linked HA can significantly improve fine lines as well as skin texture
      • Painless application
      • In office procedure with application device and consumables
      • Companion treatment to injectable crosslinked HA
      • Topical cosmecutical (non crosslinked)
  • 35. Topical Hyaluronic Acid (HA) Clinical Model
    • The stabilized cream is applied topically onto the skin containing crosslinked (non crosslinked) HA
    • The nano-spheres helps penetrate the skin layers with the aid of absorption enhancers and releases the HA into the deep layers of the skin
    • HA incorporated into the dermis (rapid aesthetic benefit) and induces long term collagen synthesis
  • 36.
    • A Double Blind Vehicle Controlled Trial to Investigate the efficacy and tolerance of Transdermal CL1 (Restylane) versus non-CL1 (Non Crossed Linked HA) in the appearance of photodamaged skin.
    •  
  • 37. Topical Hyaluronic Acid (HA) Clinical Trial
    • 100 subjects 2 sites: Women 35 – 65: 40 CL1 (crosslinked HA – Restylane), 40 NCL1 (Non crossed linked HA), 20 Vehicle
    • Patients and investigators blinded
    • 2 week wash out, 12 week trail (evaluations 2,6 and 12 weeks), 4 week post treatment (washout)
    • Apply twice a day clean face
    • Visia camera system
    • Objective evaluations
      • Goldman-Rao” photographic scale in 5 grades
      • Evaluation of skin roughness, skin hydration, skin radiance, smoothing effect, , overall efficacy and tolerance
    • Subjective Questionnaires
    .
  • 38. Clinical Evaluation: Skin Roughness
  • 39. Clinical Evaluation: Skin Hydration
  • 40. Clinical Evaluation: Skin Elasticity
  • 41. Clinical Evaluation: Skin Radiance
  • 42. Clinical Evaluation: Smoothing Effect
  • 43. Clinical Evaluation: Overall Efficacy
  • 44. Subjective Evaluation: Elasticity and Tightness
  • 45. Subjective Evaluation: Texture Improvement
  • 46. Subjective Evaluation: Skin Hydration Improvement
  • 47. Subjective Evaluation: Global Appearance Improvement
  • 48. Subjective Evaluation: Overall Efficacy
  • 49. 49
  • 50.  
  • 51.  
  • 52. 33 BEFORE 33
  • 53.  
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  • 55.  
  • 56.  
  • 57.  
  • 58.  
  • 59.  
  • 60.  
  • 61.  
  • 62. Topical Hyaluronic Acid (HA) Clinical Trial - Washout
    • Evaluation of sustained effect of topical HA
    • Effect on collagen remodeling
    • Visia photographs
    • Clinical evaluations
    • Subjective evaluations
    • Early data (70 of 100 subjects recorded)
    .
  • 63. Clinical Evaluation: Skin Roughness
  • 64. Clinical Evaluation: Skin Hydration
  • 65. Clinical Evaluation: Skin Elasticity
  • 66. Clinical Evaluation: Skin Radiance
  • 67. Clinical Evaluation: Smoothing Effect
  • 68. Clinical Evaluation: Overall Efficacy
  • 69. Topical BP Combination Acne
  • 70. InParT Drug Delivery System Topical BP: Acne I
    • BP is one of the most effective and enduring acne treatments
    • BP dramatically reduces bacteria (p. acnes) without causing bacterial resistance and in fact can reduce bacterial resistance if this has arisen from antibiotic therapy.
    • Reduces the number of yeasts on the skin surface.
    • BP is an oxidizing agent and is keratolytic and comedolytic i.e. it reduces the number of comedones
    • Anti-inflammatory action
    • Insoluble BP causes skin to look white and stain clothes
    • Prescription strength BP is a Desi Drug. Rapid FDA approval
  • 71. Topical BP: Acne Clinical Model
    • InParT can theoretically maximize penetration and delivery of BP
    • Improved efficiency
    • Minimal PB remains on skin surface to lighten skin and stain clothing
    • Delivery system can also work with BP combination compounds
  • 72. Topical BP: Acne Pilot Clinical Study
    • Objective To evaluate the efficacy of the novel INParT topical (BP 3.5%, 1.5% salicylic acid and 3% Hydrogen peroxide) in moderate to severe acne vulgaris
    • Design open-label treatment phase, randomized, parallel-group maintenance phase in comparison with VC (placebo treatment).
  • 73. Topical BP: Acne Pilot Clinical Study
    • Subjects: 26 patients (male/female 14/12) Duration acne was on average 2-3 years
    • Trial Duration: 8 week Twice a day
    • Main Outcome Measures Overall disease severity, global improvement, and lesion counts. Patients were seen at baseline, defined as the visit when treatment was initiated, and again at 2, 4, 8 weeks of treatment. Lesion count, global response and photographs
    • The global response to treatment scores were assessed by comparing the patient's condition with baseline photographs and then were graded from 0 to 6 as follows:
      • 0, completely cleared;
      • 1, approximately 90% improved;
      • 2, approximately 75% improved;
      • 3, approximately 50% improved;
      • 4, approximately 25% improved;
      • 5, no change; and
      • 6, exacerbation.
  • 74. Topical BP: Acne Pilot Clinical Study
    • Results:
      • After 8 weeks or less treatment the mean reductions from baseline in non inflammatory and inflammatory lesion count, were 66% and 69% with this novel formulation in comparison with placebo where improvement was 3.7% and 5.2%
      • At week 4, more than 80% of patients had maintained a 50% or greater global improvement from baseline, and more than 40% had maintained a 75% or greater global improvement.
  • 75. Topical BP: Acne Pilot Clinical Study
    • Results:
    • Overall disease severity score mean ± SD 3.7±1.7
    • Mean percentage (%) change in papules and pustules
    • Baseline week 1 week 2 week 4 week 6 week 8
    • 0 7.5 15.1 27.7 40.1 56.3
    • Incident of >50% global improvement from baseline 21/26
    • Incident of >75% global improvement from baseline 14/26
    • % change non-inflammatory lesions counts 64±22.2
    • % change inflammatory lesions counts 67±27.3
  • 76. Topical BP: Acne Pilot Clinical Study
    • AEs: There were no SAEs observed during this study over period
    • Most subjects reported excess dryness (24/26).
    • Redness and peeling at the site of application (9/26).
    • Burning sensation when they applied the treatment for the first time (5/26), faded after 5-7 days of the treatment.
  • 77.  
  • 78. Clinical Photographs Baseline 4 weeks
  • 79. Clinical Photographs Baseline 6 weeks
  • 80. Clinical Photographs Baseline 3 weeks 6 weeks
  • 81. Clinical Photographs Baseline 3 weeks 6 weeks
  • 82. Topical Botulinum Neurotoxin Aesthetic
  • 83. InParT Drug Delivery System Clinical Investigation
    • Animal Studies (OVC, University of Guelph, Canada)
      • Prove induction of paralysis in mice and rabbits hind legs with topical Toxin formulations in comparison with injection and placebo cream
    • Human Clinical Trials; (Acne, Cosmetic and Hyperhidrosis Indications)
      • Dr. Abel Chajchir Clinic (Argentina)
      • Dr. Guerrosantos Clinic (Mexico)
    • Asia (South Korea, Seoul and Hong Kong)
      • (Cosmetic and Hyperhidrosis)
    • USA and Canada - Future
      • (Clinical, Cosmetic and Hyperhidrosis)
  • 84. InParT Drug Delivery System Topical BoNTA: Aesthetics
    • Need for a topical neurotoxin for aesthetics
      • Painless application
      • Needle phobia
      • Fine lines (Perioral/Periorbital)
      • Pore Reduction
      • Augmentation to BoNTA injections
    • Coupled with application device for in office procedure
  • 85. Topical BoNTA: Aesthetics Clinical Model
    • The stabilized cream is applied topically onto the skin containing fixed (exact) amount of the Toxin
    • The nano-spheres helps penetrate the skin layers with the aid of absorption enhancers and releases the stabilized toxin into the deep layers of the skin
    • Toxin diffuses into the neuromuscular junctions inhibiting the release of acetylcholine and reducing muscular activity
  • 86. Topical BoNTA: Aesthetics Pilot Clinical Study I
    • Prospective blinded parallel placebo controlled trial
    • 40 female subjects 35 – 65 (20 active group 20 placebo group)
    • No previous toxin or procedures for at least 120 days (full movement)
    • Moderate or severe upper facial wrinkles (3 or 4) on a 4 point facial wrinkle scale (FWS)
    Chajchir I, Modi P, Chajchir A: Novel Topical BoNTA (CosmeTox, Toxin Type A) Cream Used to Treat Hyperfunctional Wrinkles of the Face Mouth and Neck. Aesth Plast Surg 2007
  • 87. Topical BoNTA: Aesthetics Pilot Clinical Study II
    • Novel topical InParT stabilized cream with BoNTA (Allergan) at 2 units per ml vs, cream without toxin
    • One half ml to one ml was applied daily to glabella, forehead and crows feet regions, (as well as chin and neck) for 28 to 49 days when maximum improvement was noted with most patients stopping application of active before day 35
    • Total dose per subject was 50U to 70U
    • Photographed, accessed weekly through 12 weeks
    Chajchir I, Modi P, Chajchir A: Novel Topical BoNTA (CosmeTox, Toxin Type A) Cream Used to Treat Hyperfunctional Wrinkles of the Face Mouth and Neck. Aesth Plast Surg 2007
  • 88. Topical BoNTA: Aesthetics Pilot Clinical Study III
    • Outcome Measures
      • Line severity using FWS at rest and maximum contraction
      • Subjects global assessment (SGA)
      • Facial Line Outcome questionnaire (FLO)
      • 9 point self assessment scale (SPA)
      • Subjects perception of age
    • Adverse Events
      • Type and Severity
    Chajchir I, Modi P, Chajchir A: Novel Topical BoNTA (CosmeTox, Toxin Type A) Cream Used to Treat Hyperfunctional Wrinkles of the Face Mouth and Neck. Aesth Plast Surg 2007
  • 89. Topical BoNTA: Aesthetics Pilot Clinical Study IV
    • FWS:
      • 2 weeks significantly more FWS at 2+ or less in the active group vs. placebo p< 0.0003 and at other data points P< 0.0001 maintained through 12 weeks
    • SGA
      • 2 weeks 100% of active group 25 to 50% improved vs 0 placebo p<0.0001
      • 4 weeks 85% of active group 75% or greater improved p<0.0001
    • FLO
      • 1 week significant difference and maintained throughout the study. Consistent with FWS
    • Perception of age
      • Week 12 active group 5 year +/- 2 years younger vs. 0.15 years +/- 0.37 years younger in placebo group
    Chajchir I, Modi P, Chajchir A: Novel Topical BoNTA (CosmeTox, Toxin Type A) Cream Used to Treat Hyperfunctional Wrinkles of the Face Mouth and Neck. Aesth Plast Surg 2007
  • 90. Topical BoNTA: Aesthetics Pilot Clinical Study V
    • AE’s: 3 patients in the active group experienced transient, mild AE probably related to active
      • Tight feeling in upper forehead
      • Pulling on upper eyelid
      • Dryness of skin in one area
    • Conclusions
      • Effective and appears safe
      • Need more study
    Chajchir I, Modi P, Chajchir A: Novel Topical BoNTA (CosmeTox, Toxin Type A) Cream Used to Treat Hyperfunctional Wrinkles of the Face Mouth and Neck. Aesth Plast Surg 2007
  • 91. Topical BoNTA: Aesthetics Secondary Pilot Clinical Study
    • Objective; to assess the efficacy of the Topical Toxin formulation for treatment of Glabellar, Frown lines, Crows feet and Fine lines in limited number of subject with a small dose for a period of 10 days (total dose 20 units)
  • 92. Topical BoNTA: Aesthetics Secondary Pilot Clinical Study
    • Subjects: 7 (female), ages 37-61 years
    • Treatment: subjects were treated in the clinic with 2 units/ml topical toxin cream applied on the glabella, forehead and periorbital to treat fine lines and wrinkles (crows feet), once a day for 10 days
    • The topical toxin was applied on the areas with gentle rubbing and then massaging for 60-120 seconds with a novel specially designed high frequency ultrasonic vibrator
  • 93. Topical BoNTA: Aesthetics Secondary Pilot Clinical Study
    • Results: The surface area occupied by deep wrinkles was reduced by a mean of 68% after 10 treatments. The surface area occupied by moderate wrinkles was reduced by a mean of 73% or more.
    • Glabellar lines and frown lines were reduced and showed on average 63% improvements. The results lasted for extended period of time (varied between 60 to 90 days).
    • The fine lines were reduced significantly under and around their eyes as seen from the photographs.
  • 94. Topical BoNTA: Aesthetics Secondary Pilot Clinical Study
    • Results:
    • • 97% - stated their overall cosmetic appearance had improved. • 77% - stated the visibility of their pores decreased. • 72% - stated the appearance of wrinkles decreased. • 63% - stated the appearance of glabellas and frown lines decreased
    • No product sensitivity
  • 95. Topical Toxin Before After 10 days
  • 96. Topical Toxin Before After 10 days
  • 97. Topical Toxin Before After 10 days
  • 98. Topical Toxin Before After 10 days
  • 99. Topical Botulinum Neurotoxin Hyperhidrosis
  • 100. InParT Drug Delivery System Topical BoNTA: Hyperhidrosis
    • Need for a topical neurotoxin for Hyperhidrosis
      • Painless application
      • Needle phobia
    • Coupled with application device for in office procedure
    • Allergan owns patent (2014) but can be used off label
  • 101. Topical BoNTA: Hyperhidrosis Clinical Model
    • The stabilized cream is applied topically onto the skin containing fixed (exact) amount of the Toxin
    • The nano-spheres helps penetrate the skin layers with the aid of absorption enhancers and releases the stabilized toxin into the deep layers of the skin
    • Toxin diffuses into the eccrine glands (Smooth muscles) inhibiting the release of acetylcholine and reducing sweat production
  • 102. Topical BoNTA: Hyperhidrosis Pilot Clinical Study I
    • Prospective open label study axillary and palmer hyperhidrosis
    • 24 subjects (18 – 59)
    • Starch Iodine and Gravimetric tests
    • Botulinum toxin type A gel is applied, twice a day for 1 weeks, 6 units per day. (42 units at the end of the study).
    • Weekly follow up for 12-16 weeks, with picture records, colorimetric and gravimetric test at week 4 and at the end of the study.
    • Adverse effects were recorded.
    • Patients answered a questionnaire of satisfaction at the end of the study.
    Rogelio J, Morales O: HYPERHIDROSIS TREATMENT WITH TOPIC BOTULIN TOXIN TYPE A GEL Submitted .
  • 103. Topical BoNTA: Hyperhidrosis Pilot Clinical Study II
    • Analysis Friedman Test: mg/min: 79% reduction at 12 weeks for all areas P<0.0002
    • Analysis Friedman Test: cm2: 89% reduction at 12 weeks for all areas P<0.004
    • High Satisfaction Low AE’s mostly dryness
    Rogelio J, Morales O: HYPERHIDROSIS TREATMENT WITH TOPIC BOTULIN TOXIN TYPE A GEL Submitted .
  • 104. Hyperhidrosis; Before and After ( at week 16)
  • 105. Hyperhidrosis; Before and After ( at week 16)
  • 106. InParT Drug Delivery System Future Applications
    • Hyperpigmentation and Melasma
    • Psoriasis
    • Rosacea
    • Topical Anesthesia
    • Onychomycosis
    • Xerosis
    • Cosmetics
  • 107. InParT Drug Delivery System Opportunities
    • Sale of Product
      • NTL4
      • Dermal FX
      • Acne BP
    • License Technology
    • Collaborative effort
    • Strategic Investment