-

M.D., Ph.D.

There are periods of time - when the disease is worse (called exacerbations or flares) followed by periods when the skin improves or clears up entirely (called remissions).

Atopic Dermatitis (AD)

1. Leung & Bieber, Lancet 2003;361:151-60

Atopic dermatitis is defined as a chronic, relapsing, inflammatory disorder of the skin1 characterised by an itchy red rash that starts in infants and

affects mainly children.

remissions

flares

(AD)

Guideline: Taiwan society of pediatric allergy, asthma and immunology

Atopic Dermatitis

:

1. Weston WL, Howe W. Epidemiology, clinical manifestations, and diagnosis of Atopic Dermatitis (eczema). [cited on 30th March 2011]. Available from: URL:http://www.uptodate.com/contents/epidemiology-clinical-manifestations-and-diagnosis-of-atopic-dermatitis-eczema. 2. http://emedicine.medscape.com/article/911574-overview#a0199 3. Ong PY, Boguniewicz M. Atopic dermatitis. Prim Care. Mar 2008;35(1):105-17, vii. 4. 304 5.Immunol Allergy Clin North Am. 2010 Aug;30(3):269-80. 6.Williams H et al. J Allergy Clin Immunol. 1999 Jan;103(1 Pt 1):125-38 Hwang CY et al. Acta Derm Venereol. 2010 Nov;90(6):589-94. Illi S et al. J Allergy Clin Immunol. 2004 May;113(5):925-31.

Prevalence & Incidence of AD

5~20%1

2-62

45%AD66

60%AD126

65%AD185

90%AD53

75%14(50%

75); , 25%,

2

8~10% 4

11~17% 5

(Impacts on Quality of Life)

:

(2.5) 1

2

2

1. Lewis-Jones S. Quality of life and childhood atopic

dermatitis: the misery of living with childhood eczema. Int J Clin Pract. 2006;60(8):984-92.

2. Astellas Pharma Europe Ltd.

Atopic dermatitis and the atopic march

AD could be the first step in the atopic march

Approximately 75-80% of AD patients develop allergic rhinitis (AR)

More than 50% of AD patients develop asthma

J Allergy Clin Immunol. 2003 Dec;112(6 Suppl):S118-27. Atopic dermatitis and the atopic march.

Atopic march from eczema to asthma and/or

AR

- Skin Barrier dysfunction

Allergy. 2013 Oct 14. doi: 10.1111/all.12268

TSLP(thymic stromal lymphopoietin)

Pediatrics dermatology-- 30

30%

FLG gene mutation

FLG (filaggrin):

Skin care

,

Wet wrap therapy

Protection from allergens exposure

Treatment Options

11

Guideline

2007 NICE Eczema treatment guideline

http://www.google.com.tw/url?sa=i&source=images&cd=&cad=rja&docid=1cZwwOK6HWBb3M&tbnid=h7WD_nBhMwhGIM:&ved=0CAgQjRw4Gw&url=http://www.bpac.org.nz/BPJ/2009/September/eczema.aspx&ei=qgKoUqyHK4mziAfG2YGwCA&psig=AFQjCNH_E8sFuwPNVKqET7gYQ7TPGZBFvQ&ust=1386828842772743

Atopiclair approved by FDA - Indications for Use

Under the supervision of a healthcare professional, the

product is intended for the management and relief of

burning, itching and redness associated with various types

of dermatoses, including atopic dermatitis, radiation

dermatitis and allergic contact dermatitis.

may be used to relieve the pain of first and second degree

burns.

helps to relieve dry waxy skin by maintaining a moist wound

& skin environment, which is beneficial to the healing

process.

AtopiclairTM FDA indication

atopic dermatitis,

radiation dermatitis,

allergic contact dermatitis.

may be used to relieve the pain of first and second degree burns.

helps to relieve dry waxy skin by maintaining a moist wound & skin

environment, which is beneficial to the healing process.

Atopiclair breaking the itch-scratch cycle

Atopiclair Mechanism of Action

- Three in One

Synergistic action of key ingredients

REPAIRS

Hydrating and repairing Barrier

Function

Hyaluronic acid

Shea Butter

The most powerful moisturiser known

Management of Inflammation

Glycyrrhetinic acid

Demonstrated (in vitro) ability to inhibit 11--hydroxysteroid

hydrogenase, an enzyme responsible for metabolising

hydrocortisone CALMS

Itch Management/ Protection

Telmesteine

Vitis Vinifera

Vitamin C, E

Limits the damage caused by elastase, collagenase and matrix proteinases

PROTECTS

Atopclair as prescription

To purchase this item, you must have a valid prescription. Usage/Instructions

Please take Atopiclair Cream 100ml as prescribed by your doctor or medical professional. Direction details will be available on your medication container.

Atopiclair

(I.4022)

I

I 4022

I.4022 Hydrogel wound dressing and burn

(exudate) (50%)*

Ref. TFDA

* (1)() (2)

-60%

-50%

-40%

-30%

-20%

-10%

0%

Reduce Transepidermal Water Loss (TEWL)

Atopiclair Placebo

Efficacy of Hydration Study A Double-Blind, Vehicle-Controlled Study

- Atopiclair provided the skin barrier to reduce water lose

- Atopiclair provides hydration up to 72 hours

A Double-Blind, Vehicle-Controlled Study

Sulphate-Induced Irritant Contact

Dermatitis

Transepidermal Water Loss (TEWL) as

indicator of skin water barrier alteration

Baseline: TEWL 20 (g/m2/h) after 24hrs

irritant.

Atopiclair demonstrated benefit over

vehicle clinically meaningful outcomes.

Zhai et al. Exog Dermatol 2003;2:301305

Tested by Tewameter (TM 210)

p=0.02

p=0.04

p=0.056

24 hrs 48 hrs 72 hrs

Atopiclair = Placebo Vehicle plus some key ingredients including hyaluronate, GrA, vitis vinifera extract, and telmestine.

18-65yrs Health n=20

R Sodium lauryl sulfate (SLS)

24hrs

Atopiclair

Vehicle

Efficacy of Hydration Study A Double-Blind, Vehicle-Controlled Study

- Atopiclair provided the skin barrier to reduce water lose

- Atopiclair provides hydration up to 72 hours

Zhai et al. Exog Dermatol 2003;2:301305

Tested by Tewameter (TM 210)

Blood flow volume (BFV)

Parameter for inflammation Measured with Laser Blood Flow Monitor MBF3D

Atopiclair

Erythema was quantified by skin color reflectance Measurements using a colorimeter (Chroma Meter CR 300, Minolta, Osaka, Japan).

Skin color

Atopiclair

Atopiclair achieves fast relief from itch in less

than 3 minutes

Atopiclair achieves fast relief from itch in less than 3 minutes

Patients with mild-to-moderate AD were randomized to treatment with Atopiclair (n=72) or vehicle (n=70) for 43 days.

Assessment of itch (both Visual Analogue Scale (VAS) and ordinal scale) over time was performed using the Students t test.

Atopiclair demonstrates fast onset of itch relief in in 2.42 minutes.

Boguniewicz M. et al. J Pediatr. 2008; 152: 854-9.

22

Atopiclair achieves fast relief from itch in less

than 3 minutes

Boguniewicz M. et al. J Pediatr. 2008; 152: 854-9.

MSA063DP (Atopiclair) cream in AD infants

and children study A Multicenter, Randomized, Vehicle-Controlled Study

23

6 M-12yrs, AD pts (Hanifin&Rajkas criteria)

3 major + 3 minor

Atopiclair n=72; 3 times daily

Vehicle n=70; 3 times daily

Study Design: Randomized

Double-blind,

Parallel-group

Vehicle-controlled

Day 1 22 43

Primary endpoint: IGA at day 22 (Investigators Global Assessment)

Secondary endpoints: IGA scores at other time points

Subject/caregivers assessment of pruritus (100 mm VAS

scale and 0-3 ordinal scale),

Oset and duration of itch relief, Eczema Area and

Severity Index (EASI) at study visits, subject/caregivers

assessment of global response,

Need for rescure medication in the event of an AD flare.

R

J Pediatr 2008;152:854-9

The vehicle used in the study was a cream with an emollient base similar to that of AS063DP, such as ethylhexyl palmitate and glyceryl stereate, without the key ingredients including GrA, vitis vinifera extract, and telmestine.

Investigator's Global Assessment

(IGA)

24

,,,

http://patentimages.storage.googleapis.com/WO2011051813A1/imgf000028_0001.png

Atopiclair clear eczema in as early as 8 days

with 77% treatment success by Day 22

25

Atopiclair clear eczema in as early as 8 days with 77% treatment success by Day 22

Pediatric patients with mild-to-moderate AD were randomized to treatment with Atopiclair (n=72) or vehicle (n=70) for 43 days.

Investigators global assessment on percentage of success.

39% of pediatric patients clears atopic dermatitis in as early as 8 days, versus 0% in vehicle group.

77% treatment success by Day 22

Boguniewicz M. et al. J Pediatr. 2008; 152: 854-9.

ATOPICLAIR

,,

15-30ATOPICLAIR

27

Atopiclair Cream vs Atopiclair Lotion

Atopiclair Cream Atopiclair Lotion 40ml, 100ml 120 ml Tube Bottle

2 - Piroctone Olamine & DMDM

Hydantoin 1 - Piroctone Olamine

3 years 3 years

- original vitis vinifera glycol () extract of vitis

vinifera

Atopiclair listing

- Medical Center

AD treatment: Topical Therapy Emollients

Topical corticosteroids

Topical calcineurin inhibitors

Wet-wrap therapy

Treatments for infections

Ref. Taiwan Atopic Dermatitis Diagnosis & Treatment Guideline

Brand Class Evidences / Reference

AtopiclairTM

Medical device FDA approved indication for

AD treatment Repair Protection

J Pediatr. 2008; 152(6): 854-9 Pediatr Allergy Immunol. 2008; 19(7):619-25 J Drugs Dermatol. 2006;5(3): 236-444 J Drugs Dermatol. 2005;15(1): 31-6 Eur J Dermatol. 2005;15(1):31-6

Emollient in guideline:

Taiwan AD Management Algorithm

Mild Mild lesion

Moderate Severe lesion

30%

Emollients

(Low Potent)-> Topical Corticosteroids -> (High Potent)

Antihistaminics (As needed)

Pimecrolimus

Tarcrolimus

Oral Corticosteroids

Phototherapy Systemic immune modulators

Ref. Taiwan Atopic Dermatitis Diagnosis & Treatment Guideline

ATOPICLAIR

AtopiclairFDA (Trans-Epidermal Water Loss; TEWL)

Atopiclair

Atopiclair? Atopiclair

AtopiclairFDA GRAS (generally recognized as safe )

ATOPICLAIR ,,

Atopiclair has received marketing authorization in the US and the European

Union for symptom relief of AD(eczema) ,contact and radiation dermatitis.

72

FDA(K024367)TFDA

- (Calm) + (Protect) + (Repair)

remission

Thanks for your attention!