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 gel base):

• Tretinoin (0.04%)

• Azelaic acid (8%)

• Vitamin E (0.3%)

• Hyaluronic acid (0.5%)

Tretinoin is a retinoid medication that is effective for treating acne. Retinoids help your skin to regulate its natural oil (sebum) production, which can prevent breakouts. It also induces quicker turnover of cells, which opens pores and releases bacteria or irritants trapped inside. Tretinoin also helps reduce the appearance of wrinkles and sagging skin. The concentration of tretinoin in your formula is 0.04%.

Azelaic acid inhibits skin bacteria known to be elevated in acne, and is effective for treating acne. It 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 also helps reduce hyperpigmentation (dark spots) and redness in people with lighter-toned skin. The concentration of azelaic in your formula is 8%.

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

Hyaluronic acid is also naturally occurring and supports your skin’s ability to draw in moisture and help prevent drying.

Use the formula at nighttime, before bed (UV light in sun degrades tretinoin). Wash your face using a gentle cleanser and pat dry. Let the skin dry completely before applying the cream. Apply a thin layer to the affected areas. Avoid direct contact with your eyes and eyelids (under the eyes is ok). Wash your hands after applying.

It’s important to apply just a thin layer (a pea-sized amount over the entire affected area). Applying excessive amounts may result in caking, does not increase effectiveness, and may increase risk of side effects.

Repeat 2–3 times a week as tolerated to begin with, then gradually increase to nightly use. Initially, your skin will feel dry and potentially raw—the most important thing to do to help counteract the dryness is to moisturize. In general, dark spots begin to fade around 6–8 weeks after continued use of a tretinoin-based product, and improvement in fine lines and wrinkles may be seen around 3–6 months, but your response time may differ.

Because your skin cells need time to turn over, it may take some time to see improvement, sometimes up to 12-16 weeks. If you’ve been using the gel as directed and don’t feel like it’s working, reach out to your provider to let them know about your concerns. They may recommend using it more frequently or suggest other changes to your plan.

Nightly Defense includes moisturizing ingredients, but if you feel the treatment is too harsh or drying, you can dilute the gel with a thick moisturizing cream or ointment. You can also try using the cream less frequently (for example, every other day), and then titrate back up to using it every day. If the treatment is too harsh on your skin to the point where you can’t tolerate it, reach out to your provider to let them know about your concerns. They may recommend using it less frequently or suggest other changes to your plan.

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. Acne can manifest differently, from blocked pores (whiteheads and blackheads) to small bumps with pus (pimples), to very painful pus-filled lumps (cystic lesions).

Other factors can contribute to worsening acne, though they haven’t been definitively proven to cause acne. These include:

• Cigarette smoking

• Stress

• Too little sleep

• Certain foods

• Some makeup/cosmetics

• Menstrual cycle

• Always wear sunscreen, with an SPF of 15 or higher. Tretinoin makes your skin more susceptible to sunburn, especially during the first couple weeks of treatment. Avoid using other topicals known to cause sensitivity to the sun. Tell your provider if you are taking any medication(s) that increase sensitivity to the sun (see Important Medication Information below).

• Avoid waxing areas where you are applying tretinoin, as it can cause or worsen skin irritation.

• In the first few weeks of treatment, your skin may get worse before it gets better. As long as you can tolerate the symptoms, this shouldn’t be a reason to stop the treatment. It may take up to 7 weeks for treatment to take full effect, after which time your provider may recommend a less frequent dosing schedule. It’s important to keep the skin moisturized.

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:

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

• 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.

• Moisturizer and SPF: Hydrate and protect your skin with a moisturizer and SPF. Sunscreen 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:

• 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.

• Your Nightly Defense custom blend: Wash your face using a gentle cleanser and pat dry. Let the skin dry completely before applying the cream. Apply a thin layer to the affected areas.

• 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 spots (hyperpigmentation) 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.

• Avoid using any other topicals that contain salicylic acid, benzoyl peroxide, or other chemicals known to cause skin peeling.

• Do not use tretinoin if you are pregnant or could get pregnant. Teratogenic and embryotoxic effects have been shown in animal studies where subjects received either oral tretinoin or very large doses of topical tretinoin. Adequate and well-controlled trials have not been performed in humans, but increased spontaneous abortions and major human fetal abnormalities have occurred in pregnant women receiving other retinoids.

• People who use tretinoin may experience a number of side effects, including itching, burning, redness, and peeling, sometimes referred to as “retinoid reaction.” More serious changes like rapid blistering can occur rarely. Tretinoin also makes the skin more sensitive to light, so sunscreen in tretinoin users is a must.

• Avoid exposure to the eyes, including eyelids, mouth, angles of the nose, and mucous membranes. If contact with the eyes occurs, rinse thoroughly with large amounts of water.

• Apply only to affected areas (exposure to unaffected skin may cause irritation).

• Do not use tretinoin near heat, an open flame, or while smoking. Topical tretinoin is flammable.

• Retinoids are known to increase sensitivity to sunlight. If the skin is sunburned, treatment with topical tretinoin should be postponed until after sunburn has resolved to avoid exacerbating irritation and dryness from sunburned skin. Patients with skin photosensitivity disorders, such as porphyrias or other metabolic disorders, should be closely evaluated prior to receiving tretinoin. If sun exposure cannot be avoided during topical tretinoin therapy, sunscreen products and physical blockers from the sun including protective clothing and hats should be used. Sunlight (UV) exposure increases the inflammatory effects of tretinoin. Patients who may have significant occupational exposure to the sun and those patients with inherent sensitivity to sunlight should be particularly cautious using topical tretinoin.

• Weather extremes (e.g. wind, cold) may also be irritating to the skin.

• Topical tretinoin should be avoided in patients with eczema if possible because severe irritation is likely.

• 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

• Erythema nodosum (severe skin inflammation)

• Spontaneous fetal abortion (miscarriage)

• Teratogenesis (birth defects)

Moderate

• Edema (swelling)

• Erythema (redness)

Mild

• Rash

• Skin hyperpigmentation (dark spots)

• Skin hypopigmentation (light spots)

• Skin irritation

• Pruritus (itching)

• Xerosis (dry skin)

• Photosensitivity

Contraindications

• Tretinoin is contraindicated in pregnant patients, patients trying to get pregnant (including those undergoing fertility treatment/IVF) and in patients whose pregnancy status is unknown because of the risk of miscarriage and birth defects.

• Tretinoin is contraindicated in patients who have any history of retinoid hypersensitivity reaction to vitamin A (or other retinoids) because of the possibility of cross-reactivity among retinoids. True contact allergy to tretinoin is rare.

Precautions

• Retinoids are known to increase sensitivity to sunlight, and sunlight (UV) exposure increases the inflammatory effects of tretinoin. If the skin is sunburned, treatment with topical tretinoin should be postponed until after sunburn has resolved to avoid exacerbating irritation and dryness from sunburned skin.

• Patients with skin photosensitivity disorders, such as porphyrias or other metabolic disorders, should be closely evaluated prior to receiving tretinoin. If sun exposure cannot be avoided during topical tretinoin therapy, sunscreen products and physical blockers from the sun including protective clothing and hats should be used.

• Patients who may have significant occupational exposure to the sun and those patients with inherent sensitivity to sunlight should be particularly cautious using topical tretinoin.

• See additional precautions in the “Warnings” section above.

Drug interactions

The following is a summary of important drug interactions and does not include every possible drug interaction. A more comprehensive list is available here. Tell your healthcare provider if you take any of the following:

• (Moderate) Drugs known to be photosensitizers. These include but are not limited to the following:

  • Tetracyclines (e.g. doxycycline, tetracycline, minocycline)

  • Sulfonylureas (e.g. acetohexamide, chlorpropamide, glimepiride, glipizide, glyburide)

  • Thiazide diuretics (e.g. hydrochlorothiazide/HCTZ or any drug containing HCTZ, chlorthalidone, bendroflumethiazide, methyclothiazide, metolazone), phenothiazines (chlorpromazine, promethazine, perphenazine, thiethylperazine, thioridazine)

  • Fluoroquinolones (e.g. ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin)

• (Moderate) Photodynamic therapy: tretinoin may increase the effects of photosensitizing agents used during photodynamic therapy. Examples include porfimer, aminolevulinic acid, verteporfin, methoxsalen.

• (Moderate) Benzoyl peroxide can potentiate skin irritation caused by topical tretinoin. Avoid using in the same areas as topical tretinoin.

• (Moderate) Salicylic acid: dry skin and mucus membranes are common side effects of retinoid therapy. Using retinoids concurrently with topical drying agents like salicylic acid can increase the drying effects of retinoids.

• (Moderate) St. John’s wort (hypericum perforatum): there is a theoretical risk of additive photosensitizing effects from concurrently using St. John’s wort with other photosensitizing drugs like retinoids.

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.