This skincare plan is for your general educational and informational purposes only. It is not intended to substitute the personalized medical advice of your provider. It is essential for you to understand the potential risks and benefits of treatment.

Always follow your provider’s treatment instructions, and let them know if your symptoms persist or if you experience new symptoms or side effects after you begin treatment. If you have any questions or concerns about your treatment after reading the information provided here or in the package insert, please contact your provider for additional guidance.

Telemedicine has the advantage of convenience, but it relies on your honesty and your involvement in the process. Keep every healthcare provider informed of what you are taking. If any of the following occur, please contact your provider:

• Your health status changes or you experience new symptoms

• You experience side effects

• The medicine does not work or stops working over time

• You are prescribed new medications or change how you are taking your existing medications

Your healthcare provider has reviewed your medical information and has prescribed a Nightly Defense skincare treatment containing a custom blend of the following ingredients (plus a water-free base):

• Azelaic acid

• Ceramides

• Vitamin E (acetate)

• Magnesium ascorbyl phosphate (MAP, a stable vitamin C derivative)

• Tranexamic acid

Azelaic acid has a number of properties that affect the skin, including blocking inflammation (redness and swelling) by scavenging for free radicals (unstable molecules that damage cells) at the cellular level. It inhibits skin bacteria known to be elevated in acne. It also helps reduce hyperpigmentation (dark spots) and redness in people with lighter-toned skin.

Ceramides help with moisture retention to prevent dryness and dullness.

Vitamin E acetate is a naturally occurring antioxidant that protects your skin against free radicals.

MAP (magnesium ascorbyl phosphate) is a stable vitamin C derivative that helps improve the appearance of dark spots (hyperpigmentation) and creates smoother, brighter-looking skin. Like other forms of vitamin C, MAP is an antioxidant and helps reduce unstable free radicals.

Tranexamic acid helps reduce the appearance of fine lines.

Wash face and pat dry. Apply a thin layer of cream to affected areas on your face and massage gently into the skin. Wash hands after applying. Do not cover the area after applying. Repeat nightly before bedtime.

If you have a cold sore (oral herpes), avoid applying the cream to the area of the cold sore. Exacerbations of cold sores have been reported. It may take about 3–4 weeks of using azelaic acid to see improvement in inflammation and redness. The length of treatment may be different for each person and depend on how severe the symptoms are.

Azelaic acid is not well studied in patients with darker complexions and should be used with caution to avoid hypopigmentation (lightening of the skin).

Avoid contact with the mouth, eyes, and other mucous membranes. If exposure to the eye occurs, wash with large amounts of water and contact your provider if irritation persists.

There are several best practices you can follow to take care of your skin. When using skincare products, always wash your face first. In general, products should be applied from thinnest to heaviest, for example, cleanser/toner first, then serum, then prescription cream. Always use sunscreen, at least SPF 15.

General healthy habits that may also be good for the skin include avoiding smoking, healthy habits, and drinking plenty of water.

Below is a basic regimen to help you take care of your skin and protect it from visible signs of aging.

Morning:

1. Cleanser: Use a gentle, non-lathering cleanser like the Roman Antioxidant Face Cleanser to remove dirt and oils without stripping the skin.

2. Antioxidant serum (optional): Antioxidants fight against skin damage that results from toxic free radicals, which are harmful to the DNA in skin cells and can lead to accelerated aging. Frequent sources of free radicals are cigarette smoke, pollution and car exhaust. These are oxidative stressors that almost everyone encounters in their day to day life. Roman’s moisturizer and cleanser both contain antioxidants like vitamin E. Other ingredients to look for in an antioxidant serum or moisturizer with antioxidants include kojic acid, alpha lipoic acid, ferulic acid, and phloretin.

3. Moisturizer with SPF: Hydrate and protect your skin with a moisturizer with SPF. Sunscreen (SPF) is the most important product that you need to use on a daily basis to protect your skin against aging and photodamage. Photodamage from UV rays increases and speeds up the aging process in the skin by damaging the DNA in skin cells. An SPF of 15 or above is sufficient for day-to-day sun exposure. However, if you will be out in the sun, like at the beach or on a hike, use a minimum of SPF 50, and apply at least 15 minutes before sun exposure and reapply every two hours.

Evening:

1. Cleanser: Use a gentle, non-lathering cleanser like the Roman Antioxidant Face Cleanser to remove dirt and oils from the day, as well as any makeup, without stripping the skin.

2. Your Nightly Defense custom blend: Wash face and pat dry. Apply a thin layer of cream to affected areas on your face and massage gently into the skin.

3. Moisturizing night cream: After cleansing your skin at night and before going to bed and thus sleeping for a prolonged period, it is important to apply a thick layer of rich creamy moisturizer to seal in moisture and hydration. The best night creams are too thick to be pumped out and usually come in a jar.

There are a number of ways the skin changes over time, both from normal aging and from sun damage. Your skin gets thinner, more fragile, and less elastic, and its ability to repair itself decreases. It also tends to get drier. Changes that occur specifically from sun damage (“photoaging”) include wrinkles, roughness, leathery skin, and changes in pigmentation.

Everyone is prone to skin changes from aging. Skin changes associated with aging and sun damage generally start becoming apparent in the late 20s and early 30s, and continue to progress as you get older.

While there are differences in how these changes manifest by race and gender (e.g., people with pigmented skin tend to get fewer wrinkles but more dark spots and men tend to have coarser facial skin than women due to thicker hair follicles), the underlying physiology is the same.

A little bit about the science at the microscopic level: As we age, the epidermis (outer layer of skin) thins, becoming more fragile and transparent. Fine lines and wrinkles may develop, particularly in people with lighter-toned skin. The main proteins that give skin its structure are collagen and elastin, which over time start to degrade and don’t regenerate as easily (partly from aging and also from sun damage, since UV light damages elastin fibers), so the skin becomes saggy and less elastic.

The skin’s general metabolism and ability to repair itself also decreases, and there is less fat just under the skin (subcutaneous) layer. Growth of skin cells is controlled in part by vitamin A, which is actually a group of compounds including retinol, retinal, retinoic acid, and others. (Of note, synthetic vitamin A derivatives used in anti-aging skin products are called retinoids.)

Redness (rosacea) and acne may also affect the skin. Rosacea tends to affect lighter skinned people over age 30 and affects women more often than men. It can be triggered by changes in temperature, heat, sunburn, and other stressors, but the exact cause is unknown. Acne may be associated with rosacea or manifest separately. Pimples form when pores (hair follicles) get clogged with oil or dead skin cells. Acne is often associated with puberty but can happen at any age.

• Do not use this product if you have any history of allergic reaction to azelaic acid or any components of this formula.

• Azelaic acid is not well studied in patients with darker complexions and should be used with caution to avoid hypopigmentation.

• Worsening or deterioration of asthma has been reported in patients treated with azelaic acid. If you have asthma and experience any signs of an asthma attack (i.e., shortness of breath, wheezing), tell your provider.

• Azelaic acid is classified as pregnancy risk category B by the FDA. Embryotoxic effects were seen in animal studies when given orally; no teratogenic effects were observed. There are no adequate and well-controlled studies in pregnant women. Azelaic acid should only be used during pregnancy if clearly needed.

• See below under “Important Medication Information” for more on warnings.

The information below is taken from the Prescribers’ Digital Reference (PDR), which can be found here.

Side Effects

The following is a summary of important potential side effects and does not include every side effect possible. Be sure to read all accompanying information with your medication and report any side effects you experience whether on the list below or not.

Severe

• Angioedema (allergic reaction involving severe swelling)

Moderate

• Erythema (redness)

• Edema (swelling)

• Contact dermatitis

• Wheezing

• Dyspnea (shortness of breath)

• Ocular inflammation

Mild

• Paresthesias (abnormal sensation)

• Pruritus (itching)

• Xerosis (dry skin)

• Skin irritation

• Rash

• Skin hypopigmentation

• Hypertrichosis (increased hair growth)

• Urticaria (hives)

Contraindications

• Azelaic acid is contraindicated in patients who have any history of hypersensitivity reaction to azelaic acid or any components in the formulation.

Precautions

• Avoid applying azelaic acid to cold sores (herpes labialis). Exacerbations of oral herpes have been reported.

• Patients with darker complexions should be monitored for early signs of hypopigmentation (lightening of the skin) during treatment. Azelaic acid is not well studied in people with darker complexions and should be used with caution to avoid hypopigmentation.

• Avoid contact with the mouth, eyes, and other mucous membranes. If exposure to the eye occurs, wash with large amounts of water and contact your provider if irritation persists.

• Worsening or deterioration of asthma has been reported in patients treated with azelaic acid. If you have asthma and experience any signs of an asthma attack (i.e., shortness of breath, wheezing), tell your provider.

• Azelaic acid is classified as pregnancy risk category B by the FDA. Embryotoxic effects were seen in animal studies when given orally; no teratogenic effects were observed. There are no adequate and well-controlled studies in pregnant women. Azelaic acid should only be used during pregnancy if clearly needed.

Drug interactions

There are no drug interactions associated with azelaic acid products.