Presentation on theme: "A Novel Topical Transdermal Delivery System"— Presentation transcript:
1A Novel Topical Transdermal Delivery System Mark S. Nestor, M.D., Ph.D.DirectorCenter for Clinical and Cosmetic ResearchAventura Florida
2Topical Drug and Cosmetic Delivery The skin is a formidable barrier against environmental assaults as well as topical drug deliveryA variety of active compounds have significant activity in the skin, subcutaneous tissue or muscle but cannot adequately permeate the intact skinDiseases 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 tissueSolutions to a 100+ billion dollar marketIonic Nano Particle Technology (InParT) is a novel and unique passive delivery system that can be utilized to assist the transport of a variety of active compounds to target sites in the skin and beyond
3InParT 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
4InParT Drug Delivery System Ionic Nano Particle Technology II Nano particles are made from combinations of micelles (surfactants and protein solubilizers), coated with lipid moleculesNano paticles size; less than 1-10 nano meters smaller than the skin poresNano Particles Physically entraps active without any changes in the chemical compositionStabilizes the actives: shelf stable at room temperature for extended period of time without refrigeration)Uses all FDA approved ingredients
5InParT Drug Delivery System Ionic Nano Particle Technology III INParT technology is highly adaptable to most high molecular weight drugs, proteins, peptides and insoluble hydrophobic moleculesCapable of delivering more than one therapeutic agent at a timeOffers high market value by featuring maximum functionality at minimum system complexity and costThe technology is easily scalable to any size without any complex new equipments need (no capital expenditure, commercially viable)
8InParT Drug Delivery System Clinical Investigation Topical Hyaluronic AcidTopical LidocaineAcneBenzoyl Peroxide (BP)Topical Botulinum Neurotoxin Type A (BoNTA)RhytidsHyperhidrosisFuture Developments and Partnerships
10InParT Drug Delivery System Topical Hyaluronic Acid (HA) HA crosslinked or non crosslinked difficult to adequately penetrate the stratum corneumIf adequate penetration can be achieved topical cross linked HA can significantly improve fine lines as well as skin texturePainless applicationCompanion treatment to injectable crosslinked HATopical cosmecutical
11Topical Hyaluronic Acid (HA) Clinical Model The stabilized cream is applied topically onto the skin containing crosslinked (non crosslinked) HAThe nano-spheres helps penetrate the skin layers with the aid of absorption enhancers and releases the HA into the deep layers of the skinHA incorporated into the dermis (rapid aesthetic benefit) and induces long term collagen synthesis
12A 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
13Topical Hyaluronic Acid (HA) Clinical Trial I 100 subjects 2 sites: Women 35 – 65 with moderate to severe photodamage: 40 CL1 (crosslinked HA – Restylane), 40 NCL1 (Non crossed linked HA), 20 Vehicle2 US sitesSubjects and investigators blinded2 week wash out, 12 week trail (evaluations 2,6 and 12 weeks), 4 week post treatment (washout)Apply twice a day clean face.
14Topical Hyaluronic Acid (HA) Clinical Trial II Visia camera systemObjective evaluationsGoldman-Rao” photographic scale in 5 gradesEvaluation of skin roughness, skin hydration, skin radiance, smoothing effect, overall efficacy and toleranceSubjective Questionnaires :Product QualitiesSubjective improvement.
15Topical Hyaluronic Acid (HA) Clinical Trial - Washout Evaluation of sustained effect of topical HAPatient discontinued all Topicals at day 90 and were evaluated for sustained effects at day 120Visia photographsClinical evaluations.
49Assessment of Product Overall Qualities of the Cream
50Topical Hyaluronic Acid (HA) 90 Day Results Summary I Blinded Investigator evaluations showed highly statistically significant improvement using the topical crosslinked HA (Restylane) over time and vs the non cross linked and vehicle in Skin Roughness, Hydration, Elasticity, Radiance, Smoothing Effect and Overall Efficacy. Most dramatic differences with Smoothing Effect and Overall EfficacyBlinded subjective evaluations showed highly statistically significant improvement using the topical crosslinked HA (Restylane) over time and vs the non cross linked and vehicle in, Hydration, Elasticity and tightness, Texture improvement,, Global Appearance Improvement and Overall Efficacy.
51Topical Hyaluronic Acid (HA) 90 Day Results Summary II Overall the non crosslinked HA showed better efficiency than the vehicle but was inferior to the crosslinked HAWrinkle evaluation using Goldman-Rao scale was to course a measurement to show statistical differences but clinical photos showed significant improvement using the crosslinked HATolerance: 97 out of 100 patients finished the trial. No dropout because of tolerance issues. No significant complaints of irritation, dryness, itching or redness. No investigator observed untoward effects. Subjects liked the product texture, color, penetration, and ease of application.
52Topical Hyaluronic Acid (HA) Washout Results Summary Blinded Investigator evaluations showed highly statistically significant continued improvement after 30 day washout using the topical crosslinked HA (Restylane) vs the non cross linked and vehicle which overall lost significant ground on improvementDramatic clinical improvement after washout period in categories of skin roughness, smoothing effect and overall efficiency.
53Topical Hyaluronic Acid (HA) Discussion Topical crosslinked HA (Restylane) and non crosslinked HA appears penetrate the skin using the unique Ionic Nano Particle Technology (InParT) delivery systemTopical crosslinked HA (Restylane) and to a lesser extent non crosslinked HA appear to have significant aesthetic enhancement effect in this double blind vehicle controlled trial in virtually every category of blinded investigator evaluations and subjective evaluations as well as in clinical photographic assessmentsThe benefits of the topical crosslinked HA (Restylane) continue to improve even when the product is discontinued perhaps indicating a long term benefit to the skin brought forth by collagen remodelingEarly discussion with regulatory attorneys indicates that topical crosslinked HA probably does not need an NDA and can be sold as a cosmecutical.
71Center for Clinical and Cosmetic Research (CCCR), Aventura, Florida 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°Center for Clinical and Cosmetic Research (CCCR), Aventura, FloridaMark S. Nestor, M.D., Ph.D.
72DisclosureNTL4 is an experimental topical Anesthetic owned by Innovatech, Inc.LMX4 is a commercially available topical anesthetic owned by Ferndale LaboratoriesClinical studies results in this presentation are preliminaryStudies preformed at CCCR in Aventura, Florida and Manhattan Beach, California. Mark S. Nestor, M.D., Ph.D., Principle Investigator, Glynis Ablon, M.D., Co InvestigatorFunding provided by a Research Grant from Innovatech, Inc.
73NTL4NTL4 is a unique 4% Lidocaine TA based on the INParT drug delivery systemThe INParT drug delivery system allows for rapid and efficient transfer of the Lidocaine through the stratum cornenum, epidermis and dermis to the sensory nerves4% lidocaine is ideal because of it OTC FDA indicationClinical 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 controlThe initial trial investigated the efficacy and safety comparing a 20 minute application of both productsThe second trial accessed early onset efficacy at 5, 10, and 15 minute application of both products
74CCCR Protocol 10025Double 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
75Study 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 study30 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 removedInvestigator and patient assessments completed at screening /injection immediately upon injection, at 1 hour and 3 hours at visit 1Follow-up assessments completed at Visit 2 (next day)AE and concomitant medication review / update at each visitAE, adverse event.
76Results 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 LMX4Subjective assessment of level of pain indicated clear but not significant trend favoring NTL4 over LMX4Subjects 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)
77Results 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 injectionsThere were no apparent differences in the injection related AE’s for either NTL4 or LMX4
78CCCR ProtocolDouble 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
79Study 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 study20 patients total for 2 sites randomized left and right to NLT4 or LMX4, respectively (30 second massage)3 group randomization for onset of effectiveness: 15, 10 and 5 minute duration of topical cream prior to injectionInvestigator and patient assessments completed at screening/injection Immediately upon injection, at 1 hour and 3 hours at Visit 1Follow-up assessments completed at Visit 2 (next day)AE and concomitant medication review / update at each visitAE, adverse event.
80Results 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
81Results 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
82Results 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.
83Efficacy Results: Subjective VAS Early Onset (5 Minutes) (N=6) X Axis: Time After InjectionY Axis: VAS ScaleN= N= N=6p= p= p=0.643d=0.61 (Large) d=0.27 (Small)
84Subjective Level of Pain Early Onset (5 Minutes) (N=6) LMX4NTL4Product_Randomization4321CountModerate PainMild PainMinimal PainNo PainSubject_Level_of_PainBar ChartP=0.079
86Blinded Investigator’s Evaluation of Pain Early Onset (5 Minutes) (N=6) LMX4NTL4Product_Randomization4321CountMild PainMinimal PainNo PainSubject_Level_of_PainBar ChartP=0.076
87VAS Comparison: Onset Immediate Post Injection N= N= N= N=6p= p= p= p=0.045d=0.98 (Large)X Axis: Duration of ApplicationY Axis: VAS ScaleRLX 085-rev bh jb.ppt
88Discussion ITrails 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 LMX4Results 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 painNTL4 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)
89Discussion IIAE’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 abilityNano technology allows for enhanced rapid penetration of lidocaine through the stratum corneum, epidermis and dermis to the sensory nerves4% lidocaine allows for OTC status: both as a physician used (dispensed) and general consumer useShort incubation times (early onset) will be very attractive to dermatologists and pediatriciansCommercial launch of OTC within months (just need stability testing)
90Center for Clinical and Cosmetic Research NTL4 (4% Topical Lidocaine Anesthetic Utilizing a Novel Micelle Nano Technology Delivery System): Anesthetic Properties and Lidocaine ToxicityMark S. Nestor, M.D., Ph.D.Glynis R. Ablon, M.D.Center for Clinical and Cosmetic Research
91Introduction IA recent study showed that NTL4 (Innovatec, Inc), a new topical nanotechnology lidocaine preparation, was significantly more effective than L.M.X.4® (Ferndale laboratories), a commercially available topical lidocaine preparation at decreasing pain upon injection of Restylane in the nasolabial folds.The preparation worked in as little as 5 minutes.Because of the improved capabilities of NTL4 this study will evaluate absorption and potential systemic effects of lidocaine.
92Introduction IIThe objective of this clinical study is the detection of lidocaine levels in blood after the application of up to 60 grams of NTL4 under occlusion for 60 minutes on the face, abdomen or thighs of ten study participants.Additionally a needle stick test using a subjective VAS pain scale will be used to determine efficacy of the NTL4. Analysis will include comparison of mean VAS scores for the treated and non treated areas.
93Methods I 10 subjects between 25 and 65 Blood samples (approximately 3-5cc each) were drawn from each participant at baseline (before NTL4 cream is applied*) following central laboratory instructions.NTL4 cream was applied (30 grams) on the whole face of 4 volunteers. Three volunteers had 60 grams of the cream applied on a 600 cm2 area on their abdomen and the remaining three on their thighs under plastic wrap occlusionThe cream was applied on different areas of the body to determine differences in absorption.
94Methods IINTL4 cream was left on the area for at least 60 minutes. After the 60 minutes, the cream was completely removed using tongue depressors and lint-free wipes as well as alcohol wipes. A second blood sample was taken at this time.Blood samples were taken again at 2, 6 and 24 hours post initial application of the anesthetic creamThe VAS (Visual Analog Pain) scale was used to determine the effectiveness of the topical anestheticThe subject was asked to evaluate the pain experienced at needle stick in the area covered by the topical anesthetic as well as an untreated adjacent area, by responding to a pain intensity scale.
96Results IPatients’ lab results were negative for any level of lidocaine or lidocaine metabolites.No neurological, cardiovascular, or gastrointestinal indications of lidocaine toxicity were observed.In 100% of the patients raw scores of the VAS showed that patients reported less pain upon needle stick on the treated area when compared to the non-treated area. Table 1 illustrates descriptive data for number of patients, mean scores, and standard deviations for VAS scores on treated and non-treated areas
97Results II Table 1. VAS Scores N M SD Treated 10 1.1 .95 Non TreatedA one-way analysis of variance was used to test mean differences between the 2 areas. Results indicated that a significant difference exists between the treated and non-treated areas (F [1,18] = 21.0, p<.001).
99Discussion NTL4 is an extremely effective topical anesthetic Moderate amounts of NTL4 (up to 60 grams under plastic wrap occlusion) showed no blood levels of lidocaine or metabolitesDramatic reduction in VAS pain scale to needle stickNTL4 safe and effective topical anesthetic
101InParT Drug Delivery System Topical BP: Acne I BP is one of the most effective and enduring acne treatmentsBP 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 comedonesAnti-inflammatory action
102InParT Drug Delivery System Topical BP: Acne II Insoluble BP causes skin to stain clothes need better alternativesPrescription strength BP is a Desi Drug. Rapid FDA approval but FDA transitioning to OTC designationOTC BP is a tremendous market opportunityThe active ingredient in Proactiv product is BP: $500,000,000 in annual salesTotal market OTC BP is approximately $2,000,000,000Low dose BP in InParT delivery can be more effective with fewer side effects (irritation and dryness)
103Topical BP: Acne Clinical Model InParT can theoretically maximize penetration and delivery of BPImproved efficiencyMinimal PB remains on skin surface to lighten skin and stain clothingDelivery system can also work with BP combination compounds
104Topical 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 vulgarisDesign open-label treatment phase, randomized, parallel-group maintenance phase in comparison with VC (placebo treatment).
105Topical BP: Acne Pilot Clinical Study Subjects: 26 patients (male/female 14/12) Duration acne was on average 2-3 yearsTrial Duration: 8 week Twice a dayMain 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 photographsThe 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; and6, exacerbation.
106Topical 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.
107Topical BP: Acne Pilot Clinical Study Results:Overall disease severity score mean ± SD 3.7±1.7Mean percentage (%) change in papules and pustulesBaseline week 1 week 2 week 4 week 6 week 8Incident of >50% global improvement from baseline 21/26Incident of >75% global improvement from baseline 14/26% change non-inflammatory lesions counts 64±22.2% change inflammatory lesions counts ±27.3
108Topical BP: Acne Pilot Clinical Study AEs: There were no SAEs observed during this study over periodMost 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.
115Introduction IHyperhidrosis is considered a chronic disorder that is characterized by excessive sweating in the axilla, palm, soles, or faceInjection of abobotulinumtoxin, Botox is approved by the FDA for the treatment of severe primary axillary hyperhidrosis but many patients do not tolerate the extensive injectionsAdditionally a large market exists for individuals who would like to “cosmetically” stop perspiration for an extended period of time without the need for injections
116Introduction IIThe InParT Transdermal Delivery System has been shown to have significant efficacy for passively transporting botulinum toxin both for aesthetic benefits as well as hyperhidrosisMultiple dose trials outside USIn US pilot study, 3 different FDA approved toxins will be utilized in single dose treatment regime to determine initial efficacy of the delivery system
117InParT Drug Delivery System Topical BoNTA: Hyperhidrosis Need for a topical neurotoxin for HyperhidrosisPainless applicationNeedle phobiaCoupled with application device for in office procedureAllergan owns patent (2014) but can be used off label
118Topical BoNTA: Hyperhidrosis Clinical Model The stabilized cream is applied topically onto the skin containing fixed (exact) amount of the ToxinThe nano-spheres helps penetrate the skin layers with the aid of absorption enhancers and releases the stabilized toxin into the deep layers of the skinToxin diffuses into the eccrine glands (Smooth muscles) inhibiting the release of acetylcholine and reducing sweat production
119Topical BoNTA: Hyperhidrosis Pilot Clinical Study I* Prospective open label study axillary and palmer hyperhidrosis24 subjects (18 – 59)Starch Iodine and Gravimetric testsBotulinum 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 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.
120Topical BoNTA: Hyperhidrosis Pilot Clinical Study II* Analysis Friedman Test: mg/min: 79% reduction at 12 weeks for all areas P<0.0002Analysis Friedman Test: cm2: 89% reduction at 12 weeks for all areas P<0.004High Satisfaction Low AE’s mostly dryness*Rogelio J, Morales O: HYPERHIDROSIS TREATMENT WITH TOPIC BOTULIN TOXIN TYPE A GEL Submitted.
123Topical Botulinium Toxin in the Treatment of Hyperhydrosis Mark S. Nestor, M.D., Ph.D.Glynis R. Ablon, M.D.Center for Clinical and Cosmetic ResearchConfidential Preliminary Data
124Methods 15 subjects 2 US sites Baseline axillary hyperhydrosis as defined by gravimetric test (>50 mg sweat per 5 minutes)No antiperspirant or deodorant for 3 days before and during trailOne axilla single topical treatment:5 subjects: 300 units of Dysport in InParT transport system5 subjects: 100 units of Botox in InParT transport system5 subjects: 2500 units of Myobloc in InParT transport systemContralateral axilla: InParT transport system aloneUnder occlusion for 60 minutesEvaluated at 15 and 30 days with gravimetric and starch iodine
130Patient 1Baseline hyperhydrosis as defined by gravimetric test (>50 mg sweat per 5 minutes)No antiperspirant or deodorant for 3 days before and during trailOne axilla single topical treatment with 300 units of Dysport in unique InParT transport systemContralateral axilla treated with InParT transport system aloneBoth under occlusion for 60 minutes
131Patient 1 Baseline Control Topical Dysport Gravimetric Tests 129.0mg mg
132Patient 1 Day 8 Control Topical Dysport Gravimetric Tests 120.2 mg mg
133Patient 1 Day 8 Control Topical Dysport Gravimetric Tests 120.2 mg mg
134Patient 1 Day 14 Control Topical Dysport Gravimetric Tests 128.1 mg mg
135Patient 1 Day 14 Control Topical Dysport Gravimetric Tests 128.1 mg mg
136Patient 1 Day 30 Control Topical Dysport Gravimetric Tests 100.9 mg mg
137Patient 1 Day 30 Control Topical Dysport Gravimetric Tests 100.9 mg mg
138DiscussionPilot study with 3 toxins (Botox, Dysport and Myobloc) to determine effect of a single low dose topical applicationAll three topical toxins showed effectOverall a 20% decrease over control with 100% of subjects having lower amounts of perspiration on the treated side at day 15 and 80% at day 30Individual subjects had up to 90% reduction at day 15 and 80% at day 30Need further clinical trails to optimize dosing and application
139InParT Drug Delivery System Future Applications Hyperpigmentation and MelasmaPsoriasisRosaceaOnychomycosisXerosisCosmeuticalHair Growth
140InParT Drug Delivery System Opportunities Partnership vs. License TechnologyEnhance existing topical toxinHALidocaineHydroquinoneCollaborative effortStrategic InvestmentSale