Kelo-cote®
Kelo-cote
Agenda

Market

Pathogenesis

Scar Management

Kelo-cote profile

Clinical evidence

Competitors

SWOT

Positioning: Targets

Activity plan

Strategy
Kelo-cote
Epidemiology
 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)
Kelo-cote
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
1Sund
B. New developments in wound care. London: PJB Publications, 2000:1-255. (Clinical Report CBS 836)
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 silicone
occlusive 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.
2Lewis
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.
Kelo-cote
Abnormal 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
Kelo-cote
Hypertrophic vs Keloid
Kelo-cote
Pathogenesis
 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
 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
Characteristics
Treatment
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
patients1.
Cryotherapy
Application of liquid Nitrogen,
recurrrence.
Surgery
In complicated hypertrophic scars
(infections) and in keloids ( as a 2nd line
of treatment when corticoids, pressure
etc. do not work)
Radiotherapy
Particulate radiation consisting of high
speed electrons. Adverse effects: Hypoand hyperpigmentation, erythema,
telangiectasia*, and atrophy.
Impregnated
elastic sheet
Aesthetics and uncomfortables.
Compressive
treatment
Compressive costumes (Burn units) 20 –
24 hours a day.
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
1Mustoe,
32:82–92
T.A.: "Evolution of Silicone Therapy and Mechanism of Action in Scar Management", Aesthetic Plastic Surgery 2008;
Kelo-cote
Product profile
 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
 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
 Presentations
Kelo-cote 60
g.
Kelo-cote 15
g.
Kelo-cote 6 g.
Kelo-cote
Spray 50 ml
Kelo-cote
Spray 100 ml
Kelo-cote
Mode of action
 Mechanism of action theory
http://www.kelo-cote.ca/resources/kelo-cotevideo.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
Kelo-cote
History


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
Vs Dermatix
Key points of differentiation between Kelo-cote® and the current formulation of
Dermatix®(Hanson formula):
Kelo-cote
Clinical evidence
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”
Sepehrmanesh M. Observational study of 1522 patients using Topical Silicone gel. Kompendium Dermatologie 2006; 1:30–32
Kelo-cote
Clinical evidence
Overall Efficacy rated as “good” or “very good” by over 81%
Sepehrmanesh M. Observational study of 1522 patients using Topical Silicone gel. Kompendium Dermatologie 2006; 1:30–32
Kelo-cote
Clinical evidence
 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
Sepehrmanesh M. Observational study of 1522 patients using Topical Silicone gel. Kompendium Dermatologie 2006; 1:30–32
Kelo-cote
Clinical evidence
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
1. Kelocote significanty reduces all the key measurements using the Vancouver Scar
Scale (VSS)
Sebastian G et al. Effectiveness and compatibility of silicone gel with the treatment of different scars. Act Dermatol 2004; 30
Kelo-cote
Clinical evidence
RESULTS BY SCAR TYPE
Type of scar (%)
Linear
Hypertrohic
scar
41%
Widespread
Hypertrophic
scar
6%
Mature Scar
10%
Major Keloid
10%
Immature
scar
17%
Minor Keloid
16%
Sebastian G et al. Effectiveness and compatibility of silicone gel with the treatment of different scars. Act Dermatol 2004; 30
Kelo-cote
Clinical evidence
RESULTS BY AGE OF SCARS
Age of scar (%)
>24 months
21%
< 3months
27%
12-24 months
11%
6-12months
23%
3-6 months
18%
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
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)
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
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)
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.
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
Competitors
Plant
Based
Extracts
Silicone
Sheets
Silicone
Gels
Corticoids
Creams &
Lotions
Polyureth
ane
Sheets /
Tape
Kelo-cote
Competitors
PLANT EXTRACTS
– No clinical efficacy
– Shown to create irritation
– Expensive treatment regimen as
multiple daily applications
– Limited patient compliance
CREAMS AND LOTIONS
– Provide moderate hydration
– No clinical evidence
– May cause irritation
SILICONE GEL SHEETS
– Similar efficacy
– Create maceration, itching,
dermatitis
– Require fixation
– Poor patient compliance
– Unsightly
– Need to wash regularly
– Expensive treatment regimen
SILICONE GELS
–
–
–
–
KC patented Formula
KC most clinical Evidence
Some stain clothes
Some remain tacky
Kelo-cote
Competitors
With Silicone
100% Silicone
Without 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.net
France
Spain
15gr.
15 gr.
60gr.
High price
- Formula changes
- Not high promotion (sales
force)
-
Germany
15gr.
60gr.
UK
15gr.
Italy
60gr.
60 gr.
Sheet clear
Sheet clear
Sheet fabric
Sheet fabric
15 gr.
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 Kelocote (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 wounddressing
• 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
Patients
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
Plastic surgeons
Message, concept and visual must represent
Dermatologist
-
Pharmacist
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
Key Visuals
Kelo-cote
Key Visuals
Kelo-cote
Activities
MATERIALS
CONFERENCES
PROJECTS
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
Kelo-cote
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
PROJECTS
Kelo-cote
Conferences
Conferences / Congresses
- Target: Plastics surgeons and Derms
- Objective: Present them Kelocote,
prescriptors, contact KOL.
CONFERENCES
Kelo-cote
Strategy
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
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.
KELOCOTE
Summary
CONTACT US
www.sinclairpharma.com