Kelo-cote Epidemiology Each year 100 MILLION PATIENTS worldwide acquire scars as a result of surgical procedures and trauma 1. About 15 MILLION of these patients will suffer from abnormal scars in the form of HYPERTROPHIC SCARS and KELOIDS 1. 1 Sund B. New developments in wound care. London: PJB Publications, 2000:1-255. (Clinical Report CBS 836)
Scars are treated in 55 million elective operations and 25 million operations following trauma 1 Hypertrophic scars may develop in approximately 39% to 68% of patients after surgery (and in 33% to 91% of patients after burns) 2, ³ Keloid scars may develop in 5% to 15% of wounds⁴ In 2011 > 200 million incisions made in the world each year on children and adults 5 Prevention is not a common procedure Kelo-cote Market 1 Sund B. New developments in wound care. London: PJB Publications, 2000:1-255. (Clinical Report CBS 836) 2 Lewis WH, Sun KK. Hypertrophic scar: a genetic hypothesis. Burns. 1990;16:176-8. 3 Niessen FB, Spauwen PH, Robinson PH, Fidler V, Kon M. The use of silicone occlusive sheeting (Sil-K) and silicone occlusive gel (Epiderm) in the prevention of hypertrophic scar formation. Plast Reconstr Surg. 1998;102:1962-72. 4 Cosman B, Crikelair GF, Ju DM, Gqulin JC, Lattes R. The surgical treatment of keloids. Plast Reconstr Surg. 1961;27335- 358. 5 Longaker MT. Regenerative medicine: a surgeon's perspective. J Pediatr Surg. 2010 Jan;45(1):11-7; discussion 17-8.
Kelo-cote Skin scarring Scars result from the biological process of wound repair in the skin and other tissues when the dermis is damaged. The body forms new collagen fibers to mend the damage, resulting in a scar. The new scar tissue will have a different texture and quality to the surrounding tissue. Abnormal scars can cause unpleasant symptoms and be aesthetically distressing, disfiguring, and psychosocially and functionally disabling. Appropriate treatment depends on scar type and etiology.
NORMAL WOUND HEALING Normal skin wound healing is a highly complex cascade of local and systemic events and can be categorised into three: 1. Haemostasis and inflammation 2. Proliferation 3. Remodeling Shih B, Garside E, McGrouther DA, et al. Molecular dissection of abnormal wound healing processes resulting in keloid disease. Wound Repair Regen. 2010;18:139-53 Kelo-cote Pathogenesis
Kelo-cote Pathogenesis DYSREGULATED BALANCE BETWEEN PROLIFERATION AND REMODELING Theory: abnormal wound healing process, involving increased and prolonged proliferation phase, with an excess collagen deposition by fibroblasts, and delayed remodeling phase. Shih B, Garside E, McGrouther DA, et al. Molecular dissection of abnormal wound healing processes resulting in keloid disease. Wound Repair Regen. 2010;18:139-53
Kelo-cote Scar management 1º Line of treatment and prevention of scars Mustoe TA, Cooter RD, Gold MH et al. International clinical recommendations on scar management, Past Reconstrtr Surg 2002; 110: 560-71
Kelo-cote Scar management Mustoe TA, Cooter RD, Gold MH et al. International clinical recommendations on scar management, Past Reconstrtr Surg 2002; 110: 560-71
Kelo-cote Scar management Treatment 1º Line CharacteristicsTreatment 2º line Characteristics Silicon sheets Decreases the volume and increases the elasticity of scars in 60 to 100% of cases Laser Expensive, effective, side effects (hyperpigmentation) Silicone gel Thin layer that dries, similar outcomes than SGS with better acceptability by patients 1. Cryotherapy Application of liquid Nitrogen, recurrrence. Impregnated elastic sheet Aesthetics and uncomfortables.Surgery In complicated hypertrophic scars (infections) and in keloids ( as a 2nd line of treatment when corticoids, pressure etc. do not work) Compressive treatment Compressive costumes (Burn units) 20 – 24 hours a day. Radiotherapy Particulate radiation consisting of high speed electrons. Adverse effects: Hypo- and hyperpigmentation, erythema, telangiectasia*, and atrophy. Cortisone cream / injections Efficacy but second effects Hypopigmentation around the injection site, dermal atrophy, delayed wound healing, telangiectasia*, etc. Pharmaceutic al therapies Example: 5-FU, Bleomicyn, Imiquimod, onion extract, Vitamin E. Telangiectasia*: permanent dilation of preexisting small blood vessels, creating focal red lesions 1 Mustoe, T.A.: "Evolution of Silicone Therapy and Mechanism of Action in Scar Management", Aesthetic Plastic Surgery 2008; 32:82–92
Kelo-Cote: - Kelo-cote® is a patented topical silicone gel for the management and prevention of abnormal scars in the form of hypertrophic scars and keloids. - Kelo-cote® was acquired by Sinclair in September 2010 for France, Spain, Italy, Germany and UK from ABT, an American company. - Sinclair IS acquired global rights to product excluding US in December 2011. - Medical Device (Class I MD) - Composition: Polysiloxane, Silicon Dioxide. - Patented formulation Kelo-cote Product profile
Kelo-cote Product profile Indications: - Kelo-cote Advanced Formula Scar Therapy is intended for the management of old and new hypertrophic and keloid scars resulting from general surgical procedures, trauma, wounds and burns. - Kelo-cote is suitable for use in children and people with sensitive skin. Posology: - Application in thin layer on dry skin 2 times/day - Dry in 4 to 5 minutes - Treatment duration 2 to 3 months
Kelo-cote Product profile Kelo-cote 60 g. Kelo-cote 15 g. Kelo-cote 6 g. Kelo-cote Spray 50 ml Presentations Kelo-cote Spray 100 ml
Kelo-cote Mode of action Mechanism of action theory http://www.kelo-cote.ca/resources/kelo-cote- video.html
Kelo-cote Results EFFICACY for old and new scars Reduces redness Softens, flattens and smoothes raised scars Relieves itching, discomfort and pain associated with scars
Self-dries to an invisible, breathable sheet within 4–5 minutes Transparent, odourless gel Easy and painless to apply – no removal necessary Ideal for any irregular skin/scar surfaces, the face, moving parts (joints, flexures) and any size of scars No need to shave the area before application Direct continuous contact with skin provides improved scar management Cosmetics and sun block can be applied over dried Kelo-cote ® No maceration Kelo-cote Benefits
Kelo-cote® (ABT), Dermatix® (Valeant) and Scarfade® (Hanson) Prior to mid-2007 Dermatix® = Kelo-cote® (Polysiloxanes, Silicon dioxide) During 2007 the agreement between ABT and Valeant ended. Valeant then entered into a contract with Hanson Medical, Inc. to manufacture Dermatix® (different formulation), the same for Scarfade (US only) New Dermatix composition Polixylosanes, Dimethicone. The original formulation of the Kelo-cote® brand has not changed since issue of US patent on April 21, 1998. Valeant Pharma ABT Hanson Kelo-cote History
Key points of differentiation between Kelo-cote® and the current formulation of Dermatix®(Hanson formula): Kelo-cote Vs Dermatix
Title: 2006. Scar Management: Observational study of 1522 patients using Kelo-cote® Objectives: Evaluate the efficacy of Kelo-cote® in treating redness, itchiness, pain, elevation and pliability of scars. 1522 patients Patient tolerability of Kelo-cote® treatment was also a key parameter assessed. Results: 80% of physicians rated Kelo-cote® as very good and good in relation to improvement in symptoms and in efficacy. 98% physicians rated tolerability of treatment as very good and good. Sepehrmanesh M. Observational study of 1522 patients using Topical Silicone gel. Kompendium Dermatologie 2006; 1:30–32 Kelo-cote Clinical evidence
Over 98% of physicians and patients rated tolerability as “good” or “very good” Kelo-cote Clinical evidence Sepehrmanesh M. Observational study of 1522 patients using Topical Silicone gel. Kompendium Dermatologie 2006; 1:30–32
Overall Efficacy rated as “good” or “very good” by over 81% Kelo-cote Clinical evidence Sepehrmanesh M. Observational study of 1522 patients using Topical Silicone gel. Kompendium Dermatologie 2006; 1:30–32
Conclusions: ―The observational study demonstrates the effectiveness of the product, as proven by the relief of scar symptoms ―The product is highly tolerable in use, and both physicians and patients are satisfied with Kelo-cote Key messages: ―Efficacy, tolerability, Physician and Patient satisfaction ―Silicone gels have been used and recognised as 1 st line treatment for scars for over 20 years ―Efficacious in reducing symptoms associated with abnormal scarring, it is successful in the treatment of all scars, old or new and on any skin type and various injuries including surgery, trauma and burns ―Very successful mono-therapy i.e. without any concomitant therapy ―Tolerability: Patients and physicians evaluated tolerability as “very good” or “good” representing high consistency in the evaluations ―Physicians and Patient satisfaction: Patient compliance is very high Kelo-cote Clinical evidence Sepehrmanesh M. Observational study of 1522 patients using Topical Silicone gel. Kompendium Dermatologie 2006; 1:30–32
Title: 2004. Efficacy and Tolerability of a Novel, Silicone Gel for Scar Treatment Objectives: Evaluation of efficacy and collection of safety data in clinical parameter of scars: Redness, pain, hardness, elevation and itchiness following treatment with Kelo-cote®. 111 patient surveillance study Different scar types at different ages were evaluated. Results: Patients: Efficacy 80.1% rated as very good Investigators: Efficacy 75.7% rated as very good Patients: Tolerability 89.2% rated as very good Investigators: Tolerability 84.2% rated as very good. Sebastian G et al. Effectiveness and compatibility of silicone gel with the treatment of different scars. Act Dermatol 2004; 30 Kelo-cote Clinical evidence
Sebastian G et al. Effectiveness and compatibility of silicone gel with the treatment of different scars. Act Dermatol 2004; 30 1. Kelocote significanty reduces all the key measurements using the Vancouver Scar Scale (VSS) Kelo-cote Clinical evidence
Sebastian G et al. Effectiveness and compatibility of silicone gel with the treatment of different scars. Act Dermatol 2004; 30 RESULTS BY SCAR TYPE Kelo-cote Clinical evidence
RESULTS BY AGE OF SCARS Sebastian G et al. Effectiveness and compatibility of silicone gel with the treatment of different scars. Act Dermatol 2004; 30 Kelo-cote Clinical evidence
Conclusions: ―The efficacy of Kelo-cote ® silicone gel is comparable with other topical scar therapies in the treatment of hypertrophic scars and keloids ―Silicone gel sheets have been recommended as first line therapy for the prevention and therapy of hypertrophic scars and keloids despite aspects of compliance for discomfort ―Kelo-cote® silicone gel provides easy handling and comfort to scar management Key messages: ―Efficacy on Old and New Scars: Improvement of scar symptoms using Kelo-cote® In the treatment of hypertophic and keloid scars ―Kelo-cote® significantly reduces all the key scar measurements using the Vancouver Scar Scale (VSS) ―The efficacy of Kelo-cote® silicone gel is comparable with silicone gel sheets in the treatment of hypertrophic scars and keloids but Kelo-cote® is easier to use which enhances patient compliance and the prospect of an aesthetically acceptable scar. Sebastian G et al. Effectiveness and compatibility of silicone gel with the treatment of different scars. Act Dermatol 2004; 30 Kelo-cote Clinical evidence
Signorini M, Clementonil MT. Clinical evaluation of a new self-drying silicone gel in the treatment of scars: A preliminary report. 2007; Aesth Plast Surg 31:183–187 Title: 2007. Clinical Evaluation of a New, Self-Drying, Silicone Gel in the Prevention of Hypertrophy in New Scars: A Preliminary Report Objectives: Verify the efficacy Kelo-cote® vs the conventional treatments (pressure garments, intralesional steroids, or traditional silicone gel sheeting). 160 patient Rate of fresh surgical scars and patient compliance were also key parameters assessed. Prospective, randomized, parallel-group 80 patients with Kelo-cote ® / 80 patients had no treatment unless they showed signs of hypertrophy Patients evaluated over a 6 month period Patients were evaluated following the excision of benign or malignant skin lesions (Also included scar revision and cosmetic surgery) Kelo-cote Clinical evidence
Signorini M, Clementonil MT. Clinical evaluation of a new self-drying silicone gel in the treatment of scars: A preliminary report. 2007; Aesth Plast Surg 31:183–187 Results: 67% of patients who used Kelo-cote® had no scar 72% of patients who used no treatment had a scar 25% of patients who used no treatment had hypertrophic scars or Keloids The majority (26%) of the scars that did form on the Kelo-cote® arm were mildly hypertrophic Scar classified as: Grade 1 - Normal skin Grade 2 - Mildly hypertrophic Grade 3 - Elevated (hard, dark pink to dark red) Grade 4 - Very elevated (very hard, red to brown colour, outside wound margins) Kelo-cote Clinical evidence
Signorini M, Clementonil MT. Clinical evaluation of a new self-drying silicone gel in the treatment of scars: A preliminary report. 2007; Aesth Plast Surg 31:183–187 Kelo-cote Clinical evidence Conclusions: ― Self-drying silicone gel is appealing because no fixation is required; it is invisible when dry; and sun blocks, makeup, or both can be applied in combination ― Friction by clothes also may contribute to early removal of the silicone film. These features suggest that the reported product could currently be the most recommendable agent for scar treatment, especially in visible areas Key Messages: ―Effectiveness: Improvement of scar symptoms. ― Tolerability: No side effects such as maceration, rashes or infections ― Physician and patient satisfaction: No fixation is required; it is invisible when dry; and sun block, cosmetics, or both can be applied in combination. The most recommendable agent for scar treatment, especially in visible areas.
PLANT EXTRACTS –No clinical efficacy –Shown to create irritation –Expensive treatment regimen as multiple daily applications –Limited patient compliance PLANT EXTRACTS –No clinical efficacy –Shown to create irritation –Expensive treatment regimen as multiple daily applications –Limited patient compliance SILICONE GEL SHEETS –Similar efficacy –Create maceration, itching, dermatitis –Require fixation –Poor patient compliance –Unsightly –Need to wash regularly –Expensive treatment regimen SILICONE GEL SHEETS –Similar efficacy –Create maceration, itching, dermatitis –Require fixation –Poor patient compliance –Unsightly –Need to wash regularly –Expensive treatment regimen CREAMS AND LOTIONS –Provide moderate hydration –No clinical evidence –May cause irritation CREAMS AND LOTIONS –Provide moderate hydration –No clinical evidence –May cause irritation SILICONE GELS –KC patented Formula –KC most clinical Evidence –Some stain clothes –Some remain tacky SILICONE GELS –KC patented Formula –KC most clinical Evidence –Some stain clothes –Some remain tacky Kelo-cote Competitors
With Silicone100% SiliconeWithout Silicone Kelo-cote Competitors
Dermatix gel: Main competitor +- - Management of keloid /Hypertrophic scars -Clinical studies -Dry in 4-5 minutes -Lange rank of products (gel and sheets) -Well know brand in Spain, Italy and France. -Direct sales www.dermatix.netwww.dermatix.net - High price - Formula changes - Not high promotion (sales force) France 15gr. 60gr. Sheet clear Sheet fabric Spain 15 gr. Italy 15 gr. 60 gr. UK 15gr. 60gr. Sheet clear Sheet fabric Kelo-cote Competitors Germany 15gr. 60gr.
Kelo-cote SWOT Analysis STRENGTHS - Good brand identity Large and complementary range - Unique formula silicon gel patented - Non-invasive application compared to steroids injections used for old scars - No side-effects - Home treatment - Easy to use - Colorless (invisible) - Odorless encourage treatment compliance - Cosmetics and sun block can be applied over dried Kelo-cote ® WEAKNESSES -We do not have Kelo-cote studies. Clinical studies are under DERMATIX brand. -We cannot prove our superiority of Kelo- cote (No comparative studies) -Derms don´t seem very interested -Not for hospital use -Not be applied to open or fresh wounds -Burns area : with spray ref, only 6 weeks treatment for 180cm 2 -Price strategy: cost effectiveness ratio is key for launch
Kelo-cote SWOT Analysis OPPORTUNITIES - Large scar market - No UV on the market - Aesthetic takes importance and become a systematic request after surgery procedure despite of the quality of the stitches, cicatrization is a long-term process. few competitors: most of them on silicone wound- dressing only one on silicone gel (Dermatix) - High public prices on the market currently THREATS - Multiples targets - High price - We need to have a specific plan of action in order to deliver the right message to the right target: In Spain: Plastic Surgeons, derms In France: Derms, hospitals, Pharmacies In Italy: Plastic surgeons In Germany: Derms, Plastic surgeons In UK: Derms, Plastic surgeons, hospitals - KOLs are waiting for « something » on cicatrization environment with clinical proofs - Avoid final consumer - Minimize pharmacist role -Competitors on field with high notoriety
Kelo-cote Targets Scaring risk group: 10-30 age group Women are more than twice as likely as men to purchase scar products Children are also treated with scar reduction products more frequently than men. (55% women, 30% children, 15% men) Abnormal scars: Black people, Latins Data: Galileo
Kelo-cote Influential targets Message, concept and visual must represent -Stronger scientific concept than beauty concept -Credible product (consistent formula) -Safety and efficacy, clinical evidence -Higher patient compliance with Kelo-cote than with sheets -Quick to dry and patented formula Message, concept and visual must represent -More scientific concept than beauty concept -Recommendation by plastic surgeons -Safety and efficacy, clinical evidence -Different mode of action to other products on the market
Kelo-cote Materials iPad : Target: Plastic surgeons and derms 5 slides Clinical studies / results Graphics and pictures Pathology Management of scars Clinical evidence Product information
Kelo-cote Materials Brochures - Target: pharmacies - Product information - Recommended by experts - Mechanism of action - Mode of use Kakemono (banner) - Target: pharmacies Display - Target: pharmacies
Kelo-cote Materials Sachets: - Target: Plastic surgeons and derms - Presentation: 0,5 g. - Leaflet for the patient: - Product information and way to use. Patient brochure : - What are scars - Product information - Recommended by experts - Mechanism of action - Mode of use Mode of use : «Like a grain of rice» «Like a drop» thin cover to get dry Mode of use : «Like a grain of rice» «Like a drop» thin cover to get dry
Kelo-cote Projects PROJECTS Projects: -Target: Plastic surgeons and derms -Objetive: Get involve the doctors in scars management E.g.: Ask them to share pictures of scars for articles to be published on our website
Kelo-cote Conferences CONFERENCES Conferences / Congresses -Target: Plastics surgeons and Derms -Objective: Present them Kelocote, prescriptors, contact KOL.
Strategy KOL support: Plastic surgeons and Derms Legitimacy of Kelo-cote: ―Kelo-cote is internationally recommended as the first line of treatment for the prevention and treatment of Hypertrophic scars and Keloids ―Differenciation from DERMATIX (Mode of action, patient compliance, efficacy, easy to use) Kelo-cote Strategy
Kelo-cote Potential Issues Controversy Kelocote Vs Dermatix Clinical Studies under the Dermatix brand Old lists: Dermatix still list in pharmaceutical books as ABT formulation New target: Plastic surgeons Derms: are not very interested, less surgeries, new procedures without scar formation.