Atopic® 0.

1% Ointment
Back to The Typical Life

Saleem Alawneh
Regional Product Manager
Atopic Dermatitis
 Overview- Atopic dermatitis (AD)
Atopic dermatitis (eczema) is a condition that makes skin red
and itchy.

It's common in children but can occur at any age. AD is chronic

and tends to flare periodically. It may be accompanied by
asthma or hay fever.

No cure has been found for AD, but treatments and self-care
measures can relieve itching and prevent new outbreaks.
 Symptoms
Vary widely from person to person and include:
• Dry skin Itching, which may be severe, especially at night.

• Red to brownish-gray patches.

• Small, raised bumps, which may leak fluid and crust over when scratched.

• Thickened, cracked, scaly skin.

• Raw, sensitive, swollen skin from scratching.

AD most often begins before age 5 and may persist into adolescence and adulthood. For some
people, it flares periodically and then clears up for a time, even for several years.
 Causes
• Healthy skin helps retain moisture and protects you from bacteria, irritants and
allergens. Eczema is related to a gene variation that affects the skin's ability to
provide this protection. This allows your skin to be affected by environmental
factors, irritants and allergens.
• In some children, food allergies may play a role in causing eczema.
Risk factors
• The primary risk factor for atopic dermatitis:
Family history of eczema | allergies | hay fever | asthma
 Complications
• Asthma and hay fever: More than half of young children with atopic dermatitis develop asthma and hay fever
by age 13.

• Chronic itchy, scaly skin: Starts with a patch of itchy skin. When scratch the area, which makes it even
itchier. This condition can cause the affected skin to become discolored, thick and leathery.

• Skin infections: Repeated scratching that breaks the skin can cause open sores and cracks. These increase
the risk of infection from bacteria and viruses, including the herpes simplex virus.

• Irritant hand dermatitis: This especially affects people whose work requires that their hands are often wet
and exposed to harsh soaps, detergents and disinfectants.

• Allergic contact dermatitis: This condition is common in people with AD.

• Sleep problems: The itch-scratch cycle can cause poor sleep quality.
 Prevention
1. Moisturize your skin at least twice a day. Creams, ointments and lotions seal in moisture.

2. Try to identify and avoid triggers that worsen the condition. These triggers include: sweat, stress, obesity,
soaps, detergents, dust and pollen.

3. Infants and children may experience flares from eating certain foods, including eggs, milk, soy and wheat.

4. Take shorter baths or showers. Limit your baths and showers to 10 to 15 minutes. And use warm, rather than
hot water.

5. Use only gentle soaps. Choose mild soaps. Deodorant and antibacterial soaps can remove more natural oils
and dry your skin.

6. Dry yourself carefully. After bathing gently pat your skin to dry with a soft towel and apply moisturizer while
your skin is still damp.
 Diagnosis
No lab test is needed to identify atopic dermatitis. Doctor will likely make a diagnosis by
examining the skin and reviewing patient medical history.

The doctor also may use patch testing or other tests to rule out other skin diseases or
identify conditions that accompany eczema.

The doctor may ask the patient about a certain food causes the rash, to identify potential
food allergies.
 Treatment
AD can be persistent which may need to try various treatments over months or years to
control it.

Even if treatment is successful, signs and symptoms may return (flare).

If regular moisturizing and other self-care steps don't help, doctor may suggest one or
more of the following treatments:
Medications
Corticosteroid: Cream or ointment to control the itching and help repair the skin.
 Overuse of this drug may cause side effects, including thinning skin.

Calcineurin inhibitors: Such as tacrolimus and pimecrolimus.

 They affect the immune system. These drugs have a black box warning about a potential risk of cancer. But the
American Academy of Allergy, Asthma & Immunology has concluded that the risk-to-benefit ratios of topical
pimecrolimus and tacrolimus are similar to those of most other conventional treatments of persistent eczema
and that the data don't support the use of the black box warning.

 Although a causal relationship has not been established, rare cases of malignancy (ie, skin cancer and
lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including tacrolimus
ointment. Avoid continuous long-term use of topical calcineurin inhibitors, including tacrolimus ointment, in
any age group, and limit application to areas of involvement with atopic dermatitis.
 Medications
Drugs to fight infection: 
 An antibiotic cream - if the skin has a bacterial infection, an open sore or cracks.
 oral antibiotics for a short time to treat an infection.

Oral drugs that control inflammation. 

 For more-severe cases,
 oral corticosteroids — such as prednisone.
 These drugs are effective but can't be used long term because of potential serious side
effects.
Vitiligo
 INTRODUCT
IONdisappearance of melanocytes,
• Vitiligo is characterized by the progressive
resulting in depigmentation of the skin.
• The etiology of vitiligo is unknown. Vitiligo is a multifactorial, polygenic
disorder. The autoimmune theory remains the most widely accepted.
• Vitiligo has frequently been reported in association with autoimmune
disorders such as thyroid disease, diabetes mellitus and alopecia areata.
• Several studies have suggested that the presence of increased
antimelanocyte antibodies and the imbalance of T-cell subsets, along with
their functional defects, may result in melanocyte destruction in vitiligo
patients.
• The disease affects both genders equally. It can appear at any age and the average age of onset is
somewhat variable in different geographic regions.  
• Vitiligo treatment remains a challenge.
• Therapeutic options for vitiligo include:
 Topical and systemic corticosteroids
 Topical calcineurin inhibitors
 Pseudocatalase
 Calcipotriol
 Phototherapy
 Excimer laser
 Surgical methods such as skin grafting, autologous cultured melanocyte or epidermal suspension
transplantations.
• Topical corticosteroids are most commonly used drug to treat vitiligo but there
are concerns over side effects due to long-term use. Steroid application causes
skin atrophy, hypertrichosis and acne.
• Tacrolimus and pimecrolimus are used as topical Immunomodulators. They
inhibit calcineurin action, thus preventing T-cell activation and the production of
various inflammatory cytokines.
• Both have been used to treat other inflammatory and immunologic skin
disorders, including vitiligo, with encouraging results.
Psoriasis
• Psoriasis typically affects the outside of the elbows, knees or scalp,
though it can appear on any location.
• Some people report that psoriasis is itchy, burns and stings.
• Psoriasis is associated with other serious health conditions, such as
diabetes, heart disease and depression.
 How do I get psoriasis?
• Not know what exactly causes psoriasis, the immune system and genetics play major
roles in its development. Usually, something triggers psoriasis to flare.
• The skin cells in psoriasis grow at an abnormally fast rate, which causes the buildup of
psoriasis lesions.
• Men and women develop psoriasis at equal rates. Psoriasis also occurs in all racial
groups, but at varying rates.
• Psoriasis often develops between the ages of 15 and 35, but it can develop at any age.
• About 10% to 15% of those with psoriasis get it before age 10. Some infants have
psoriasis, although this is considered rare.
• Psoriasis is not contagious.
 How is psoriasis
diagnosed?
• There are no special blood tests or tools to diagnose psoriasis. A dermatologist
usually examines the affected skin and determines if it is psoriasis.
• The doctor may take a piece of the affected skin (a biopsy) and examine it under
the microscope. When biopsied, psoriasis skin looks thicker and inflamed when
compared to skin with eczema.
• The doctor also will investigate about family history. About one-third of people
with psoriasis have a family member with the disease.
Type of
psoriasis?
There are five types of psoriasis:
1- Plaque Psoriasis

• Plaque psoriasis is the most common form of the disease and appears
as raised, red patches covered with a silvery white buildup of dead
skin cells.
• These patches or plaques most often show up on the scalp, knees,
elbows and lower back.
• They are often itchy and painful, and they can crack and bleed.
• 2- Guttate
• Guttate [GUH-tate] psoriasis is a form of psoriasis
that appears as small, dot-like lesions.
• Guttate psoriasis often starts in childhood or young
adulthood, and can be triggered by a strep
infection.
• This is the second-most common type of psoriasis.
About 10 percent of people who get psoriasis
develop guttate psoriasis.
3- Inverse
• Inverse psoriasis shows up as very red lesions in
body folds, such as behind the knee, under the
arm or in the groin.
• It may appear smooth and shiny.
• Many people have another type of psoriasis
elsewhere on the body at the same time.
4- Pustular
• Pustular [PUHS-choo-lar] psoriasis in characterized by white
pustules (blisters of noninfectious pus) surrounded by red skin.
• The pus consists of white blood cells. It is not an infection, nor is it
contagious.
• Pustular psoriasis can occur on any part of the body, but occurs
most often on the hands or feet.
5- Erythrodermic
• Erythrodermic [eh-REETH-ro-der-mik] psoriasis is a
particularly severe form of psoriasis that leads to
widespread, fiery redness over most of the body.
• It can cause severe itching and pain, and make the
skin come off in sheets.
• It is rare, occurring in 3% of people who have
psoriasis during their life time. It generally appears on
people who have unstable plaque psoriasis.
• Individuals having an Erythrodermic psoriasis flare
should see a doctor immediately. This form of
psoriasis can be life-threatening.
 Where does psoriasis show up?
• Psoriasis can show up anywhere. The skin at each site is different and requires
different treatments.
• Light therapy or topical treatments are often used when psoriasis is limited to a
specific part of the body. However, doctors may prescribe oral or injectable drugs
if the psoriasis is widespread or greatly affects the quality of life.
Scalp
Very mild, with slight, fine scaling. It can also be very severe with thick, crusted plaques covering the entire
scalp. Psoriasis can extend beyond the hairline onto the forehead, the back of the neck and around the ears.
Face
Most often affects the eyebrows, the skin between the nose and upper lip, the upper forehead and the
hairline. Psoriasis on and around the face should be treated carefully because the skin here is sensitive.

Hands, Feet and Nails

Treat sudden flares of psoriasis on the hands and feet promptly and carefully. In some cases, cracking,
blisters and swelling accompany flares. Nail changes occur in up to 50% of people with psoriasis and at
least 80% of people with psoriatic arthritis.

Genital Psoriasis
The most common type of psoriasis in the genital region is inverse psoriasis, but other forms of psoriasis can
appear on the genitals, especially in men. Genital psoriasis requires careful treatment and care.

Skin Folds
Inverse psoriasis can occur in skin folds such as the armpits and under the breasts. This form of psoriasis is
frequently irritated by rubbing and sweating.
 Psoriasis Severity
• Psoriasis can be mild, moderate or severe.
• The treatment options may depend on how severe psoriasis is.
• Severity is based on how much of the body is affected by psoriasis. The entire
hand (the palm, fingers and thumb) is equal to about 1% of the body surface
area. 
• However, the severity of psoriasis is also measured by how psoriasis affects a
person's quality of life. For example, psoriasis can have a serious impact on one's
daily activities even if it involves a small area, such as the palms of the hands or
soles of the feet.
 MILD MODERATE SEVERE
Less than 3% Between 3% & 10% More than 10% of the
of the body. of the body body
 Treatment
• Topical treatments, such as moisturizers, OTC and prescriptions
creams and shampoos, typically are used for mild psoriasis.
• Treating moderate to severe psoriasis usually involves a combination
of treatment strategies.
• Besides topical treatments, the doctor may prescribe phototherapy
• Doctor may also prescribe systemic medications, including biologic
drugs, especially if psoriasis is significantly impacting your quality of
life.
 Will I develop psoriatic
arthritis?
• About 11% of those diagnosed with psoriasis have also been diagnosed with
psoriatic arthritis. However, approximately 30% of people with psoriasis will
eventually develop psoriatic arthritis.
• Psoriatic arthritis often may go undiagnosed, particularly in its milder forms.
However, it's important to treat psoriatic arthritis early on to help avoid
permanent joint damage.
Topical calcineurin Inhibitors
(TCI)
• TCI are used as topical Immunomodulators. They inhibit calcineurin
action, thus preventing T-cell activation and the production of various
inflammatory cytokines.
• Tacrolimus and Pimecrolimus have been used to treat other inflammatory
and immunologic skin disorders, including vitiligo, with encouraging
results.
 Back to The Typical Life

Atopic® 0.1% Ointment

Tacrolimus monohydrate
 Immunosuppressive drugs or immunosuppressive agents 
•  are drugs that inhibit or prevent activity of the immune system. They are used in immunosuppressive
therapy to:
• Prevent the rejection of transplanted organs and tissues (e.g., bone marrow, heart, kidney, liver)
• Treat autoimmune diseases or diseases that are most likely of autoimmune origin (e.g., rheumatoid
arthritis, multiple sclerosis, psoriasis, vitiligo).
• A common side-effect of many immunosuppressive drugs is immunodeficiency, because the majority of
them act non-selectively, resulting in increased susceptibility to infections and decreased Cancer
immunology. There are also other side-effects, such as hypertension, dyslipidemia, hyperglycemia, peptic
ulcers, moon face, liver and kidney injury.
• The immunosuppressive drugs also interact with other medicines and affect their metabolism and action.
• Immunosuppressive drugs can be classified into five groups:
• Glucocorticoids, cytostatics, Antibodies, drugs acting on immunophilins (Tacrolimus), other drugs.
 Atopic® 0.1% Ointment
Tacrolimus monohydrate
• Tacrolimus is a macrolide antibiotic produced by Streptomyces tsukubaensis with
strong T specific immunosuppressant activity.

• The biological activity of tacrolimus takes effect by the inhibition of the

expression of several inflammatory T-cell cytokines.

• Indeed, topical tacrolimus downregulates proinflammatory cytokines, namely IL-

2, IL-3, IL- 4, IL-5, IFN-c, TNF-alfa and granulocyte-stimulating factors.
 INDICATIO
NS
1. moderate to very severe AD.

2. facial and intertriginous psoriasis.

3. vitiligo.
 BEFORE THE USE OF ATOPIC®
• Not to be used If the patient is allergic (hypersensitive) to tacrolimus or any of the other ingredients of Atopic®
or to macrolide antibiotics (e.g. azithromycin, clarithromycin, and erythromycin).
• Patient must tell the doctor if he/she:
• Has liver failure.
• Has any skin tumours or if he/she has a weakened immune system, whatever the cause.
• Has a cutaneous Graft Versus Host Disease (an immune reaction of the skin which is a common complication in
patients who have undergone a bone marrow transplant).
• Has swollen lymph nodes at initiation of treatment.
• Has infected lesions. Not to apply the ointment to infected lesions.
• Notices any change to the appearance of his/her skin, must inform the physician.
 NOTE
S
• Atopic® ointment 0.1 % is not approved for children younger than 16 years of age. Therefore it
should not be used in this age group.

Pregnancy and breast-feeding:

Not to use Atopic® in case of pregnancy or breast-feeding.
 POSSIBLE SIDE EFFECTS:
Very common (probably affecting more than 1 in 10):
• Burning sensation and itching.
These symptoms are usually mild to moderate and generally go away within one week of using Atopic®.
Common (probably affecting up to 1 in 10):
• Redness • Feeling of warmth • Pain • Increased skin sensitivity (especially to hot and cold)
• Skin tingling • Rash
• Local skin infection regardless of specific cause including but not limited to: inflamed or infected hair follicles,
cold sores, generalized herpes simplex infections
• Facial flushing or skin irritation after drinking alcohol is also common
Uncommon (probably affecting fewer than 1 in 100):
• Acne
Atopic for the treatment of Atopic Dermatitis (AD)
Safety:
Tacrolimus is more beneficial than topical corticosteroids in the treatment of patients whose AD is
poorly responsive to topical steroids and patients with corticosteroid phobia.
 
Efficacy:
Tacrolimus ointment is an effective therapy for the treatment of adult patients with AD on all skin
regions including the head and neck.
Tacrolimus ointment 0.1% is approved by the FDA for short-term and intermittent long-term use in
moderate to severe AD for adults.
Tacrolimus ointment is more effective than Pimecrolimus cream in adults with
moderate to very severe AD. 60% Results
57%
50%
49%
40%
A Study: 40% 39%
30% 34%

Number of patients: 281 patients; 20% 22%

Treatment: Tacrolimus group: 141 Patients 10%

Pimecrolimus group: 140 Patients 0%

Treatment success Improvements in the Improvements in
Eczema Area Severity percentage of Total
Duration of treatment: 6 weeks Index Score Body Surface Area
affected

Tacrolimus Column1

Journal of Dermatological Treatment, Volume 18, 2007 – Issue 3:151-157.

Atopic for the treatment of Vitiligo
Results
80%
71%
70%

60%
A study:
50%
Number of patients: 48 patients with bilateral vitiligo.
40%
Treatment: Tacrolimus 0.1% ointment, twice daily.
30%
Duration: 36 weeks.
20%

10%

0%
Repigmentation in all patients

G Ital Dermatol Venereol. 2014 Feb; 149(1):123-30

 Atopic for the treatment of facial and intertriginous psoriasis
Results
Intertriginous and facial psoriasis require a different approach Patients cleared or almost cleared
than is used for typical plaque psoriasis on other skin areas. 70.0%

60.0% 65.2%

50.0%
A study: (10) 40.0%

Number of patients: 167 patients. 30.0%

Treatment: Tacrolimus 0.1% ointment, twice daily. 20.0%

10.0%
Duration: 8 weeks.
0.0%
Percentage of patients

Journal of American Academy of Dermatology. 2004 Nov; Volume 51(5):723-730

 Atopic® 0.1% Ointment
Direction for usage:
Apply a thin layer of Atopic ointment on the affected areas of the
skin twice daily or as directed by the doctor.
Avoid the strong sunlight.
Presentation:
30gm of Atopic ointment in plastic tube.
Price:
 Atopic® 0.1% Ointment
• Atopic® Highly effective and tolerable in long term treatment for chronic conditions.
• Atopic® More effective than Pimecrolimus cream in adults with moderate to very
severe AD.
• Has less adverse effects compared with topical corticosteroids.
• Atopic® The best corticosteroid-sparing therapy for atopic dermatitis.
• Atopic® Considered as an ideal treatment for facial and intertriginous psoriasis.
• Atopic® Proven efficacy and safety for skin repigmentation in vitiligo.
Thank you