kelo-cote®. market pathogenesis scar management kelo-cote profile clinical evidence ...

Kelo-cote®

Market

Pathogenesis

Scar Management

Kelo-cote profile

Clinical evidence

Competitors

SWOT

Positioning: Targets

Activity plan

Strategy

Kelo-coteAgenda

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Abnormal scars:- generalities- main types- hypertrophic vs keloid

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Pathogenesis: normal and abnormal wound healing

Kelo-coteEpidemiology

Each year 100 MILLION PATIENTS worldwide acquire scars as a result of surgical procedures and trauma1.

About 15 MILLION of these patients will suffer from abnormal scars in the form of HYPERTROPHIC SCARS and KELOIDS1.

1Sund B. New developments in wound care. London: PJB Publications, 2000:1-255. (Clinical Report CBS 836)

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Market

Scars are treated in 55 million elective operations and 25 million operations following trauma1

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 adults5

Prevention is not a common procedure

Kelo-coteMarket

1Sund B. New developments in wound care. London: PJB Publications, 2000:1-255. (Clinical Report CBS 836)2Lewis WH, Sun KK. Hypertrophic scar: a genetic hypothesis. Burns. 1990;16:176-8.3Niessen FB, Spauwen PH, Robinson PH, Fidler V, Kon M. The use of silicone occlusive sheeting (Sil-K) and siliconeocclusive gel (Epiderm) in the prevention of hypertrophic scar formation. Plast Reconstr Surg. 1998;102:1962-72.4Cosman 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-coteSkin 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.

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Abnormal scarsGeneralities

Kelo-coteAbnormal Scars

Hypertrophic scars Red, inflamed, itchy, and even painful Remain within the boundaries of the original lesion. They can regress spontaneously after the initial injury.

Keloid scars Thick, rounded, irregular clusters of scar tissue Invade the surrounding skin. They cannot regress spontaneusly

Atrophic scars Flat and depressed They are formed following acne or chickenpox

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Abnormal scarsMain types

Kelo-coteHypertrophic vs Keloid

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Abnormal scarsHypertrophic vs keloid

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 inflammation2. Proliferation3. 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-cotePathogenesis

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PathogenesisNormal wound healing

Kelo-cotePathogenesis

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

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PathogenesisAbnormal wound healing

Kelo-coteScar 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

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Complete management algorithm

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que représentent les flèches ? et les étoiles ?

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préciser silicone = 1st line of treatment


Mustoe TA, Cooter RD, Gold MH et al. International clinical recommendations on scar management, Past Reconstrtr Surg 2002; 110: 560-71

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Scar managementSilicone as 1st line prophylaxis & treatment

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les images minor et major keloids sont bonnes


Treatment 1º Line

Characteristics Treatment2º 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 patients1.

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.

Pharmaceutical therapies

Example: 5-FU, Bleomicyn, Imiquimod, onion extract, Vitamin E.

Telangiectasia*: permanent dilation of preexisting small blood vessels, creating focal red lesions1Mustoe, T.A.: "Evolution of Silicone Therapy and Mechanism of Action in Scar Management", Aesthetic Plastic Surgery 2008; 32:82–92

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Unaesthetic?

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Efficient+ pain as second effect

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mostly for severe keloids

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Light radiation at a specific wave lenghth

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-coteProduct 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 60 g.

Kelo-cote 15 g.

Kelo-cote 6 g. Kelo-cote Spray 50 ml

Presentations

Kelo-cote Spray 100 ml

Kelo-coteMode of action

Mechanism of action theory

http://www.kelo-cote.ca/resources/kelo-cote-video.html




Kelo-coteResults

EFFICACY for old and new scars

Reduces redness Softens , flattens and smoothes raised scars Relieves itching, discomfort and pain associated with scars

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-coteHistory

Key points of differentiation between Kelo-cote® and the current formulation of Dermatix®(Hanson formula):

Kelo-coteVs 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-coteClinical evidence

Over 98% of physicians and patients rated tolerability as “good” or “very good”



Overall Efficacy rated as “good” or “very good” by over 81%



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 1st 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



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



1. Kelocote significanty reduces all the key measurements using the Vancouver Scar Scale (VSS)


Widespread Hypertrophic

scar6%

Mature Scar10%

Major Keloid10%

Minor Keloid16%Immature

scar17%

Linear Hypertrohic

scar41%

Type of scar (%)


RESULTS BY SCAR TYPE


RESULTS BY AGE OF SCARS

< 3months27%

3-6 months18%

6-12months23%

12-24 months11%

>24 months21%

Age of scar (%)



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.



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)



Results:67% of patients who used Kelo-cote® had no scar72% of patients who used no treatment had a scar25% of patients who used no treatment had hypertrophic scars or KeloidsThe majority (26%) of the scars that did form on the Kelo-cote® arm were mildly hypertrophic

Scar classified as:Grade 1 - Normal skinGrade 2 - Mildly hypertrophicGrade 3 - Elevated (hard, dark pink to dark red)Grade 4 - Very elevated (very hard, red to brown colour, outside wound margins)




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 Based Extracts

Silicone Gels

Creams & Lotions

Polyurethane Sheets / Tape

Corticoids

Silicone Sheets

Kelo-coteCompetitors

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

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


With Silicone 100% Silicone Without Silicone


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.net

- High price- Formula changes- Not high promotion (sales force)

France15gr.60gr.Sheet clearSheet fabric

Spain15 gr.

UK15gr.

60gr.

Sheet clear

Sheet fabric


Germany15gr.60gr.

http://www.dermatix.net/

Kelo-coteSWOT 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 180cm2

- 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-coteTargets

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

Patients

Kelo-coteInfluential 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

Plastic surgeons

Dermatologist

PharmacistMessage, 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-coteKey Visuals

Kelo-coteActivities

MATERIALS

PROJECTSCONFERENCES

Kelo-coteMaterials

iPad :

Target: Plastic surgeons and derms 5 slides Clinical studies / results Graphics and pictures Pathology Management of scars Clinical evidence Product information

Kelo-coteMaterials

Brochures

- Target: pharmacies- Product information- Recommended by experts- Mechanism of action- Mode of use

Kakemono (banner) - Target: pharmacies

Display- Target: pharmacies

Kelo-coteMaterials

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

Kelo-coteProjects

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-coteConferences

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-coteStrategy

Kelo-cotePotential 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.

KELOCOTESummary

www.sinclairpharma.com

CONTACT US

http://www.sinclairpharma.com/

kelo-cote®. market pathogenesis scar management kelo-cote profile clinical evidence ...

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