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Transcription

1 FOR THE TREATMENT OF ACNE VULGARIS!J ii II " 'T/ ~~ I., -- o '~( _!! í '"..,oi..', Q,~~ ~. Advance to the '" head of the êlass ~ Optimized tretinoin plus proven tolerabilty-for a smart start they can stay with! -- At:ra I i n~ (tretinoin) gel 0.05% ~

2 v. ~ EHicacv.. :JJ 'J that makes a powerful impact Combined results of two 12-week, prospective, multicenter, randomized, vehicle-controlled studies of patients with mild to moderate acne vulgaris of the face' Reduction in inflammatory Lesions Reduction in Non-Inflammatory Lesions OJ.= -5 ãj -10 '" l' II -15 E l: -20 LL OJ bl -25 c l'.. U -30 OJ bl l' -35. ĊOJ -40 r..~ Atralin~ Gel 0.05% (n=674) ~ OJ Q. -45 ""1! Vehicle (n=487) -50 o Weeks on Treatment (lntent-to- Treat Population) 20% OJ -5.= ãj -10 '" l' II '-15 E l: -20 LL OJ bl -25 c l' U OJ bl l' -35. ĊOJ -40 '=.. Atralin Gel 0.05% ("=674) ~ OJ Q. -45.=~ vehicle (n=487) ' weeks on Treatment (intent-to-treat Population) 21% Uniquely formulated for targeted delivery Micronized tretinoin fadlitates effcient delivery to the follcle*. 85% of tretinoin particles in Atralin Gel are (10 microns -Follicular openings on tne forehead can be as small as 11 microns2. Lipophilic tretinoin dissolves in sebum within the follicle -Micronized tretinoin particles in Atralin Gel are small enough to easily enter the follicular opening -Fewer tretinoin particles may remain on the skin surface,'* 'The clinical significance of micronization is unknown....

3 A smart combination. Sodium hyaluronatet -Plays a role in moisturizing the stratum corneum due to its unique water-binding properties3. Soluble collagenh -Increases the moisture content of the skin4. Glycerint for improved tolerability -Enhances the water-binding capacity of the stratum corneums tthe contribution of individual components to effcacy has not been evaluated. *soluble collagen comprises methylparaben, propylparaben, ethylparaben, butylparaben, isobutyl para ben, phenoxyethanol, fish collagen, and water. :-;,~., i. r ;;, 'I Low irritation profile --- Percentage of patients with skin-related adverse reactions reported over 12 weeks in pivotal studies' AtralinCë Gel (n=674) Dry skin Skin,burning Erythema Exfoliative dermatitis Scaling Pruritus Skin exfoliation vehicle (n=487) Please see accompanying full prescribing information. -- Atra I i n~ (tretinoin) gel 0.05%...

4 Superior delivery Tretinoin levels to the dermis at 24 hours' Mean cumulative levels of tretinoin to the dermis at 24 hours* 0.08 N Eu 0.06 bi :: r 'õ '' i: CI Atralin0 Gel Retin-A Micro0 Retin-A Micro0 (tretinoin gel) microsphere 0.1% (tretinoin gel) microsphere 0,04% 'In vitro data; clinical significance is unknown. Differences between products were not statistically significant. Indication and Important Safety Information: Atralin Gel is indicated for the treatment of acne vulgaris. The most common adverse reactions were mild to moderate irritation of the skin and occurred during the first few weeks of treatment with Atralin Gel. To prevent aggravating the skin, protect it from sun, tanning lights, extreme wind or cold, and harsh skincare products. Use of sunscreen products of at least SPF 15 and protective clothing over treated areas is recommended when exposure cannot be avoided. Atralin Gel should not be used on eczematous or sunburned skin due to potential for severe irritation.... References: 1, Data on file, CORIA Laboratories. 2. Otberg N, Richter H, Schaefer H, Blume-Peytavi U, Sterry W, Lademann l. Variations of hair follicle size and distribution in different body sites. J Invest Dermatol. 2004;122(1): Weindl G, Schaller M, Schäfer-Korting M, Korting He. Hyaluronic acid in the treatment and prevention of skin diseases; molecular, biological, pharmaceutical and clinical aspects. skin Pharmacol Physial. 2004;17(S): , Morganti P. Skin hydration. In: Magdassi S, Touitou E, eds. New Cosmetic Delivery Systems. New York, NY. Marcel Dekker, Inc; 1999: Kraft ln, Lynde CWo Moisturizers: what rthey are and a practical approach to product selection. Skin Therapy Lett. 200S;1O(S):1-8. CORIÄ L"w"''''''' -- At:ra Ii nð (tretinoin) gel 0.05% RETIN-A MICRO is a registered trademark of Ortho Dermatologies. ( 2010 CORIA iaboratories COR

5 ATRALIN (tretinoin) Gel 0.05% Page 1 of 1 \ ATRALIN (tretinoin) Gel 0.05% is a prescription acne medication that is formulated with a combination of moisturizing ingredients that you won t find in any other prescription acne treatment. Important Safety Information: The most common adverse reactions were mild to moderate irritation of the skin and occurred during the first few weeks of treatment with ATRALIN Gel. To prevent aggravating the skin, protect it from sun, tanning lights, extreme wind or cold, and harsh skincare products. Use of sunscreen products of at least SPF 15 and protective clothing over treated areas is recommended when exposure cannot be avoided. Please see Full Prescribing Information. Contact Legal Disclaimer Prescribing Information 2008 CORIA Laboratories, Ltd.

6 Why ATRALIN Gel is Right for You Page 1 of 1 ATRALIN Gel May Make It Easier to Get the Results You Want ATRALIN (tretinoin) Gel 0.05% contains tretinoin, an effective ingredient for treating acne breakouts and preventing future breakouts from happening. 1 In fact, many dermatologists prescribe a tretinoin because it works so well even on tough acne. But unlike other acne medications, ATRALIN Gel is the only tretinoin formulation that features a unique combination of ingredients that are known to moisturize and hydrate skin.* It is common for acne treatments to cause redness, burning, dryness, and peeling. 1 If you have dry or senstive skin, it can easily get irritated by acne treatments. You may be tempted to skip or stop your treatment altogether if you experience this discomfort or feel like your acne isn t getting better. That makes it impossible to succeed and get the results you want. Skin irritation is usually a main reason why you may stop your acne treatment. ATRALIN Gel offers a low potential for irritation. Chances are you ll stick with your treatment if there s less risk of irritation, which will help you get the best results. It can take up to 12 weeks to get full results so don't think your acne medication isn't working. When you see your first signs of success, it s likely just the beginning. Stick with your treatment. ATRALIN Gel can help you reach your goal. Ask your doctor about ATRALIN Gel to help you get the results you want. Important Safety Information: The most common adverse reactions were mild to moderate irritation of the skin and occurred during the first few weeks of treatment with ATRALIN Gel. To prevent aggravating the skin, protect it from sun, tanning lights, extreme wind or cold, and harsh skincare products. Use of sunscreen products of at least SPF 15 and protective clothing over treated areas is recommended when exposure cannot be avoided. Please see Full Prescribing Information. *The contribution to efficacy of individual components has not been evaluated. Reference: 1. Thiboutot D. New treatments and therapeutic strategies for acne. Arch Fam Med. 2000;9(2): Home Contact Legal Disclaimer Prescribing Information 2008 CORIA Laboratories, Ltd.

7 ATRALIN Gel for Teens Page 1 of 2 Even the Smallest Breakout Can Be Frustrating Who hasn t had an occasional pimple? But what about more serious acne the kind that affects lots of teens? 1 Statistics say guys suffer more from severe acne, 1 but let s face it acne breakouts can be tough for everyone. They may even make you feel less confident about yourself. A prescription treatment may be the answer to control your acne. But to be successful your doctor needs to choose one that s right for your skin. Not all prescription treatments are alike. They have different ingredients, formulations, and strengths factors that can contribute to irritation, which can discourage you and make you stop treatment. There are milder-strength treatments with less potential for irritation, but it may take a little longer to see results, which can be frustrating. That s why it s so important for you and your doctor to choose a treatment that's right for you. 5 reasons why ATRALIN Gel may be right for you. 1. ATRALIN (tretinoin) Gel 0.05% contains tretinoin an effective ingredient for fighting acne ATRALIN Gel has a low potential for irritation. 3 This may help make your treatment more tolerable as your acne is getting better. 3. ATRALIN Gel is formulated with a smart combination of ingredients that are known to hydrate and moisturize skin.* 4. ATRALIN Gel is an elegant aqueous gel that s designed to quickly rub in without leaving residue so it isn t noticeable. 5. ATRALIN Gel is designed to help prevent future breakouts. In a clinical study, the number of people who said they were dissatisfied by their self-appearance due to their facial acne was reduced by half after using ATRALIN Gel for 12 weeks. 3, Important Safety Information: The most common adverse reactions were mild to moderate irritation of the skin and occurred during the first few weeks of treatment with ATRALIN Gel. To prevent aggravating the skin, protect it from sun, tanning lights, extreme wind or cold, and harsh skincare products. Use of sunscreen products of at least SPF 15 and protective clothing over treated areas is recommended when exposure cannot be avoided. Please see Full Prescribing Information. *The contribution to efficacy of individual components has not been evaluated. Combining the top three categories of a patient survey, Extremely, Very Much, and Quite a Bit, the numbers dropped from 29% to 14%. References: 1. American Academy of Dermatology. What is acne? Accessed October 1, Thiboutot D. New treatments and therapeutic strategies for acne. Arch Fam Med. 2000;9(2): Data on file, CORIA Laboratories, Ltd. 4. Nemours Foundation. Why do I get acne? Accessed October 1, 2007.

8 ATRALIN Gel for Teens Page 2 of 2 Home Contact Legal Disclaimer Prescribing Information 2008 CORIA Laboratories, Ltd.

9 ATRALIN Gel for Adults Page 1 of 2 Think You re Too Old for Acne? Think Again Life is challenging enough without having to deal with the added stress of adult acne. Maybe you had acne as a teen or maybe you didn t. The truth is, adult acne can rear its ugly head in our early to mid 20s, and stay until we re 40 or older, for a variety of reasons. 1 It can also stick around for years. 1 Adult skin has special needs As we age, our skin loses moisture 2 and may be drier and more sensitive. You may benefit from an acne treatment like ATRALIN (tretinoin) Gel 0.05% because it s the only tretinoin that offers a unique combination of ingredients that are known to moisturize and hydrate skin.* 5 reasons why ATRALIN Gel may be right for you 1. ATRALIN Gel contains tretinoin an effective ingredient for fighting acne ATRALIN Gel contains a combination of ingredients that are known to moisturize and hydrate skin* making it more ideal for adult skin. 3. ATRALIN Gel has low potential for irritation. 4 This may help you look better as your acne is getting better. 4. ATRALIN Gel is an elegant aqueous gel that s designed to quickly rub in without leaving residue so it isn t noticeable. 5. ATRALIN Gel is designed to help prevent future breakouts. Important Safety Information: The most common adverse reactions were mild to moderate irritation of the skin and occurred during the first few weeks of treatment with ATRALIN Gel. To prevent aggravating the skin, protect it from sun, tanning lights, extreme wind or cold, and harsh skincare products. Use of sunscreen products of at least SPF 15 and protective clothing over treated areas is recommended when exposure cannot be avoided. Please see Full Prescribing Information. *The contribution to efficacy of individual components has not been evaluated. Tell me more about teen acne References: 1. American Academy of Dermatology. What is acne? Accessed October 1, National Institute on Aging. Skin care and aging. Accessed October 1, Thiboutot D. New treatments and therapeutic strategies for acne. Arch Fam Med. 2000;9(2); Data on file, CORIA Laboratories, Ltd. 5. Goulden V, Stables GI, Cunliffe WJ. Prevalence of facial acne in adults. J Am Acad Dermatol. 1999;41(4): American Academy of Dermatology. Millions of women facing adult acne. Press release. Accessed October 1, Home Contact Legal Disclaimer Prescribing Information 2008 CORIA Laboratories, Ltd.

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11 How to Use ATRALIN Gel Page 1 of 1 Page Title How to Use ATRALIN Gel First, wash your face with a mild, non-medicated cleanser, like CeraVe Hydrating Cleanser. Gently pat dry. Apply ATRALIN (tretinoin) Gel 0.05% once a day before bedtime, or as directed by your doctor. Squeeze a small amount (about the size of a pea) onto your fingertip. Dab ATRALIN Gel on your forehead, chin, and both cheeks. Using more ATRALIN Gel or using it more often than your doctor tells you to won t make it work better or faster and could cause irritation. Gently spread on your skin, avoiding your mouth, the corners of your nose, and getting too close to your eyes. Spread ATRALIN Gel away from these areas. Ask your doctor if you can use CeraVe Moisturizing Lotion/Cream after washing your face in the morning. Like many other acne medications, ATRALIN Gel can make your skin more sensitive to the sun. Avoid sunlight, sunlamps, and other medicine that may make you more sensitive to sunlight when using ATRALIN Gel. It s also a good idea to use sunscreen of at least SPF 15 when using ATRALIN Gel or any other topical medication. Ask your doctor if you have any questions about the medicines you re taking. Keep using ATRALIN Gel for as long as your doctor instructs to help get the best results. Home Contact Legal Disclaimer Prescribing Information 2008 CORIA Laboratories, Ltd.

12 ATRALIN Gel - Tips for Success Page 1 of 2 Tips for Success with ATRALIN Gel How should I use ATRALIN Gel? Wash your skin with mild, non-medicated soap and dry your skin gently. Apply ATRALIN Gel once a day before bedtime. Squeeze a small amount of ATRALIN Gel (about the size of a pea) on your fingertip. Apply ATRALIN Gel, using a thin layer to cover the entire affected area. Smooth ATRALIN Gel gently into your skin. Do not put ATRALIN Gel near your mouth, eyes, on the corners of your nose, or on open sores. Spread ATRALIN Gel away from this areas when putting ATRALIN Gel on your skin. Do not use more ATRALIN Gel than your doctor has prescribed. Do not use ATRALIN Gel more often than your doctor has told you. Too much ATRALIN Gel may irritate or increase the irritation of your skin, and will not give faster or better results. You can use a facial cream or lotion of SPF 15 or higher each morning after washing your face. Follow your doctor's advice because you need to use a cream or lotion that will not make your acne worse. You may use cosmetics with ATRALIN Gel. However, clean your face before using cosmetics and remove cosmetics from your skin before using ATRALIN Gel. Talk to your doctor about recommended cosmetics. You may not see improvement right away. ATRALIN Gel may work better for some patients than for others. Once your acne is under control you should continue to use ATRALIN Gel as your doctor instructs you to do. What should I avoid while using ATRALIN Gel? Spend as little time as possible in the sun. Use a daily sunscreen with a SPF 15 rating or higher, protective clothing, and a wide brimmed hat to protect you from sunlight. When outside, even on hazy days, areas treated with ATRALIN Gel should be protected. Do not use sunlamps or tanning beds. ATRALIN Gel may make you get sunburned more easily. If you do get sunburned, stop using ATRALIN Gel until your skin is completely back to normal. Talk to your doctor about how to protect your skin if you must be in sunlight a lot. Avoid cold weather and wind as much as possible, and use clothing to protect you from the weather. Skin treated with ATRALIN Gel may dry out or get wind burned more easily. If you don t see results right away, don t stop using ATRALIN Gel. Just because you don t see immediate results doesn t mean ATRALIN Gel isn t working. Give it the full 12 weeks. Home Contact Legal Disclaimer Prescribing Information 2008 CORIA Laboratories, Ltd.

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14 ATRALIN Gel - Your Role in Your Acne Treatment Page 1 of 1 Page Title The Real Key to Clearing Acne Is Sticking with Your Treatment for Several Weeks That s not always easy. It is common for acne treatment to cause irritation, stinging, burning, or redness, and you may be tempted to skip or stop your treatment altogether. That means you won t get the results you want. Which is why it s so important for you and your doctor to choose a treatment you can stick with to get the best results. All acne treatments are not alike They have different ingredients, formulations, and strengths factors which can contribute to irritation. That s why it s important for you and your doctor to choose a treatment you will be happy with in the long term to help you to get the best results. What to expect You may notice more pimples when you first use an acne medication. This doesn t mean it isn t working. Give it the full 12 weeks. Some people may experience a little dryness, redness or irritation with acne medications. Using an appropriate moisturizer during the day may help. If irritation persists, talk to your dermatologist. What you can do 1. Remember to apply your acne medication every day exactly as prescribed. 2. Keep your face clean, but avoid washing too much or scrubbing too hard as it can irritate your skin Keep your acne medication where you ll see it every day, like next to your toothbrush. This will help you remember to use it. 4. Avoid oily cosmetics or lotions Avoid tight helmets or tight athletic clothes Never pick or squeeze your pimples it can just make them worse Try to avoid touching your acne throughout the day. Reference: 1. National Institute of Arthritis and Musculoskeletal and Skin Disorders (NIAMS). National Institutes of Health. Questions and answers about acne. Accessed October 1, Home Contact Legal Disclaimer Prescribing Information 2008 CORIA Laboratories, Ltd.

15 ATRALIN Gel - Questions to Ask Your Doctor Page 1 of 1 Page Title Questions to Ask Your Doctor What type of acne do I have? How do prescription products differ from over-the-counter products? How often do I need to apply my medication? Does it matter what time of day I use my medication? How long will I need to use my medication? When can I expect to see some results? What should I do if I experience any redness or irritation? What other skin care products or medications should I avoid? What kind of cleanser and moisturizer do you recommend? Is it okay to wear makeup with my prescription medication? What else should I do to take care of my skin? Home Contact Legal Disclaimer Prescribing Information 2008 CORIA Laboratories, Ltd.

16 ATRALIN Gel - Acne Fast Facts Page 1 of 2 Who gets acne? Nearly 80% of people between the ages of 11 and 30 suffer from some form of acne at some point. 1 About 8 in 10 teens have acne,2 but it can also affect adults in their 20s or even 40s. 3 While there s no magical, overnight cure, acne can be controlled with the right treatment. How does acne happen? Acne occurs when the hair follicles or pores on your body become clogged with excess sebum a natural oil made from the body s oil glands (called sebaceous glands) dead skin cells, and dirt. 1 This encourages more sebum and bacteria, resulting in a plug in the pore (called whiteheads and blackheads), pimples, and even cysts. 1 Illustration of whitehead Illustration of blackhead Where does acne occur? Common sites for acne are the face, neck, chest, back, shoulders and upper arms. 3 What are other causes of acne?

17 ATRALIN Gel - Acne Fast Facts Page 2 of 2 What are other causes of acne? Researchers believe that some people are just born with a genetic tendency to develop acne. 1 Hormones also play a key role in acne, especially in teens. That s because certain hormones, called androgens, multiply during puberty and increase production of sebum. 1 Hormonal changes in pregnant women, or women who take birth control pills can also be related to acne. 1 Many women experience acne breakouts the week before their period. 1,4 What can make acne worse? 1 Oil from cosmetics Dirt or humidity in the air Tight helmets or tight athletic clothes Harsh scrubbing of skin Picking and/or squeezing pimples References: 1. National Institute of Arthritis and Musculoskeletal and Skin Disorders (NIAMS). National Institutes of Health. Questions and answers about acne. Accessed October 1, Nemours Foundation. Why do I get acne? Accessed October 1, American Academy of Dermatology. What is acne? Accessed October 1, American Academy of Dermatology. Millions of women facing adult acne. Press release. Accessed October 1, American Academy of Dermatology. Acne myths. Accessed October 1, Home Contact Legal Disclaimer Prescribing Information 2008 CORIA Laboratories, Ltd.

18 ATRALIN Gel - What Acne Can Look Like Page 1 of 2 What Acne Can Look Like Mild acne Closed comedone a plug that stays under the skin and appears as a little white bump (commonly called a whitehead). 1 Open comedone a plug that reaches the skin surface and opens up. 1 It may look like a black speck of dirt (and is commonly called a blackhead), but it s not. 1 Moderate acne Illustration of a closed comedone Papules small pink bumps on the skin surface that may be tender when touched (also called inflamed comedones). 1 Pustules red skin bumps filled with yellow or white pus (commonly called pimples). 1 Severe acne Cysts pus-filled sores that can be deep, painful, and cause scarring. 1 A comedone is the term used to describe the hair follicle or pore plugged with sebum, dead skin cells, and bacteria (also called an acne lesion). 1 Illustration of an open comedone Reference: 1. National Institute of Arthritis and Musculoskeletal and Skin Disorders (NIAMS). National Institutes of Health. Questions and answers about acne. Accessed October 1, Illustration of a papule

19 ATRALIN Gel - What Acne Can Look Like Page 2 of 2 Illustration of a pustule Home Contact Legal Disclaimer Prescribing Information 2008 CORIA Laboratories, Ltd.

20 Results with ATRALIN Gel Page 1 of 2 Results with ATRALIN Gel These before and after pictures show you how using ATRALIN (tretinoin) Gel 0.05% may often result in clearer skin.* Have you seen results with ATRALIN Gel? Tell us your story and we ll enter you in a random drawing to win. Baseline 19-year-old male Week 12* *Individual results may vary.

21 Results with ATRALIN Gel Page 2 of 2 Baseline 13-year-old male Week 12* *Individual results may vary. Home Contact Legal Disclaimer Prescribing Information 2008 CORIA Laboratories, Ltd.

22 Results with ATRALIN Gel Page 1 of 1 Coming Soon... Home Contact Legal Disclaimer Prescribing Information 2008 CORIA Laboratories, Ltd.