Now’s the time to manage your damage

Up to 58 million Americans have actinic keratosis (AK). An AK has the potential to progress to squamous cell carcinoma (SCC), the second most common skin cancer. While most AKs remain benign, approximately 10 percent develop into SCC within an average of two years.1 Since there is no way to know ahead of time which ones will become cancerous, it is very important to seek a dermatologist’s care. Frequent skin examinations are the key to early detection and prevention.
What are Actinic Keratoses (AKs)?

AKs – often called “sun spots”— are rough-textured, dry, scaly patches on the skin caused by excessive exposure to ultraviolet light (UV) such as sunlight. They occur most often on sun exposed areas such as the face, scalp or ears, and can range in color from skin toned to reddish brown. They can be as small as a pinhead or larger than a quarter.

What do AKs look like?

Actinic Keratoses generally begin as rough spots of skin that may be easier felt than seen. Common complaints include a lesion that has increased in size or one that is raised, bleeding, poor in healing, discolored, or associated with discomfort such as pain or itching.

While a lesion may initially appear skin colored to pink, red, or brown, lesions on darker skin may be more pigmented. AKs may feel soft, rough, or “gritty,” but in any case, they feel different from the surrounding healthy skin.

Since there are many clinical variants of AKs, it is best to consult a dermatologist if you suspect a lesion.

Who gets AKs?

AKs are seen primarily in Caucasians with pale skin living in sunny climates. Areas of the skin with the most sun exposure, such as the head, neck, forearms, and hands account for more than 80 percent of AKs.

Actinic Keratoses develop as the result of years of sun exposure. Because the effect of sun exposure is cumulative, it is your lifetime exposure that increases your risk. Even if you didn’t suntan much, years of just doing simple tasks outside can add up to significant amount of sun exposures. For example:

  • Going out to the mailbox
  • Playing an outdoor sport
  • Walking the dog

Because AKs take a long time to develop, they generally appear after the age of 40. The American Academy of Dermatology estimates that 60 percent of persons apt to get Actinic Keratoses will indeed get at least one AK in their lifetime.

Your risk of developing AKs increases if you have one or more of the risk factors.

What are some of the risk factors?

  • A history of cumulative sun exposure
  • Fair skin
  • Blond or red hair, in particular if combined with blue, hazel or green eyes
  • A tendency to freckle or burn after sun exposure
  • A weakened immune system

Now’s the time to manage your damage

Levulan® Kerastick® (aminolevulinic acid HCl) for Topical Solution, 20% (Levulan Kerastick) plus blue light illumination using the BLU-U® Blue Light Photodynamic Therapy Illuminator (Levulan PDT) is indicated for the treatment of minimally to moderately thick actinic keratosis of the face or scalp. Actinic keratoses (AKs) are rough-textured, dry, scaly patches on the skin that can lead to skin cancer. It is important to treat AKs because there is no way to tell when or which lesions will progress to squamous cell carcinoma (SCC), the second most common form of skin cancer. So, now’s the time to manage your damage!

Levulan PDT, a 2-part treatment, is unique because it uses a light activated drug therapy to destroy AKs.

How does it work?

Levulan Kerastick Topical Solution is applied to the AK. The solution is then absorbed by the AK cells where it is converted to a chemical that makes the cells extremely sensitive to light. When the AK cells are exposed to the BLU-U Blue Light Illuminator, a reaction occurs which destroys the AK cells.The 2-part treatment offers the following conveniences:

  • No prescription to fill
  • No daily medication to remember
  • Treatment is administered by a qualified healthcare professional

Levulan PDT can also fit your lifestyle:

  • Two treatment sessions a month apart are recommended for most patients.
  • Low downtime*
  • High ratings for cosmetic response1
  • No scarring reported to date

*Patients treated with Levulan PDT should avoid exposure of the photosensitized lesions to sunlight or prolonged or intense light for at least 40 hours.

Ask your dermatologist if Levulan PDT is right for you!

Important Risk Information

What is Levulan Kerastick used for?
The Levulan Kerastick for Topical Solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face or scalp.

Who should NOT take Levulan?
Levulan Kerastick should not be taken by patients who have cutaneous photosensitivity at wavelengths at 400-450 nm, porphyria, or known allergies to porphyrins, and in patients with known sensitivity to any of the components of the Levulan Kerastick for Topical Solution.

Levulan Kerastick has not been tested on patients with inherited or acquired coagulation defects. There have been no formal studies of the interaction of Levulan Kerastick for Topical Solution with any other drugs and no drug-specific interactions were noted during any of the controlled clinical trials. It is possible that concomitant use of other known photosensitizing agents might increase the photosensitivity reaction of actinic keratoses treated with the Levulan Kerastick. It is important to tell your physician if you are taking any oral medications or using any topical prescription or non-prescription products on your face or scalp. Tell your doctor if you are pregnant or nursing.

What are the possible side effects?
The most common side effects include scaling/crusting, hypo/hyper-pigmentation, itching, stinging, and/or burning, erythema and edema. Severe stinging and/or burning at one or more lesions being treated was reported by at least 50% of patients at some time during the treatment.

What precautions should be taken?
Patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light prior to and at least 40 hours after blue light treatment. Exposure may result in a stinging and/or burning sensation and may cause erythema or edema of the lesions. Sunscreens will not protect against photosensitivity reactions caused by visible light.

What to expect before, during and after Levulan® PDT treatment

Before Treatment Starts

  • Be sure to tell your physician if you are taking any oral medications or using any topical prescription or non-prescription products on your face or scalp.
  • Bring adequate sun-protective items with you to your appointment such as a wide-brimmed hat or umbrella.

The Levulan PDT Treatment

Treatment Step 1: Application of Levulan Kerastick Topical Solution

  • Levulan will be uniformly applied to your AK lesions.
  • Your physician will direct you to wait the recommended time in order to allow the solution to penetrate the targeted cells. Then you will return for the second part of your treatment which includes illuminating your treated lesions with the BLU-U® blue light.
  • You should not wash your face in between treatment steps.
  • Avoid exposing the treated lesions to sunlight and other forms of bright light for at least 40 hours. Examples include exam room examination lights, operating room lamps, tanning bed lights, and household lights at close range. Sunscreens will not protect against photosensitivity reactions caused by visible light during this time. Remember to wear light protective clothing, such as a wide-brimmed hat, during this time.
Treatment Step 2: BLU-U Treatment

  • Your treatment with the BLU-U will take approximately 17 minutes.
  • Protective eyewear should be worn during your BLU-U treatment.
  • You may experience stinging or burning during your BLU-U treatment, but this should subside between 1 minute and 24 hours after the BLU-U is turned off.

After Treatment

  • You may apply moisturizers as needed.
  • The most common side effects are:
    • Burning/stinging, which could be severe, may last up to 24 hours after your BLU-U treatment
    • Redness and swelling which may last up to 4 weeks after your BLU-U treatment
    • Scaling/crusting which may last up to 4 weeks after your BLU-U treatment

General precaution for sun exposure

  • On a daily basis, always remember to use sunscreen and wear sun protective clothing to shield your skin from the sun’s damaging rays.

Before and After Treatment

Baseline 24 hours 4 weeks 8 weeks 12 weeks

PHOTODYNAMIC THERAPY (PDT) using the LEVULAN® KERASTICK® for Topical Solution, 20% (generic name = aminolevulinic acid HCl) & the BLU-U® Blue Light Photodynamic Therapy Illuminator for Topical Use on the Face or Scalp.

What is LEVULAN® KERASTICK® for Topical Solution + Blue Light PDT?

This is a two-step (drug + blue light) treatment designed to treat actinic keratoses (AK) lesions on the face or scalp. AKs are precancerous skin changes caused by chronic sun exposure. If untreated, AKs may develop into skin cancer.

In the first part of the treatment, your doctor or other health care provider applies LEVULAN KERASTICK Topical Solution, using the LEVULAN KERASTICK Topical Solution applicator, to individual AK lesions of the face or scalp. Levulan is allowed to absorb for approximately 60 minutes.  You are then exposed to the  BLU-U® treatment for 17 minutes.

Clinical studies have shown that 8 weeks after LEVULAN KERASTICK for Topical Solution + BLU-U treatment, about 80% of patients had 75% or more of their treated AKs completely clear (could not be identified by sight or touch). About 65% of patients had complete clearing of all their treated AK lesions.

Four-eight weeks after the first treatment, those AK lesions which do not completely clear may be treated a second time. In clinical studies, at 12 weeks after the first treatment or four weeks after the second treatment, about 90% of the patients had 75% or more of their treated AKs completely clear. About 72% of patients had complete clearing of all their treated AK lesions.
Who should not have LEVULAN KERASTICK for Topical Solution + Blue Light PDT?
You should not have LEVULAN KERASTICK for Topical Solution + Blue Light treatment if you have:

  • skin sensitivity to blue light
  • porphyrias
  • allergies to chemicals called porphyrins

Tell your doctor if you are pregnant or nursing. It is not known if LEVULAN KERASTICK for Topical Solution can cause harm to an unborn child when administered to a pregnant woman or if it can affect the capacity to conceive a child. It is not known whether its use by a nursing mother can affect her baby. If you are pregnant, plan to become pregnant, or are nursing a baby, talk to your doctor about whether you should have LEVULAN KERASTICK for Topical Solution + BLU-U Treatment.

LEVULAN KERASTICK Topical Solution has not been tested on patients with inherited or acquired bloodclotting defects.

If any of these conditions apply to you, inform your doctor immediately.

Tell your doctor if you are using other medicines, especially if they increase sensitivity to light. These medicines include thiazides (used to treat high blood pressure), tetracyclines, fluoroquinolones, griseofulvin, or sulfonamides (used to treat infection), sulfonylureas (used to treat diabetes), and phenothiazines (used to treat serious emotional problems).

There are other medicines that may increase sensitivity to light. Therefore, if you are taking any prescription medicines, non-prescription medicines, herbal remedies (such as St. John’s Wort) or are using any medicines or creams that you put directly on your face or scalp, check with your doctor to make sure they do not interact with LEVULAN KERASTICK for Topical Solution + BLU-U Treatment.

How are actinic keratoses treated with LEVULAN KERASTICK for Topical Solution + Blue Light PDT?
After LEVULAN KERASTICK Topical Solution is applied to your AKs in the doctor’s office, you need to wait in our office for 60 minutes.   You will wear goggles to protect your eyes during the BLU-U treatment. The light is low intensity and will not heat your skin.

What should I avoid after LEVULAN KERASTICK Topical Solution is applied?
Between the time of the application of LEVULAN KERASTICK for Topical Solution and BLU-U treatment your AK lesions will become photosensitive (sensitive to light). Care should be taken to keep the areas to which LEVULAN KERASTICK Topical Solution has been applied protected from bright light during this time. You should also continue to avoid exposure of the photosensitized areas to sunlight or to bright light for at least 40 hours after application of the LEVULAN KERASTICK Topical Solution.

Light-protective headgear, such as a wide-brimmed hat of sufficient size to provide shade to areas to which LEVULAN KERASTICK Topical Solution has been applied, should be worn during this time if you are exposed to sunlight or sources of bright indoor light such as lights at close range, examination lamps or tanning beds.

If you feel burning and/or stinging of the areas to which LEVULAN KERASTICK Topical Solution has been applied, light exposure should be reduced by wearing protective headgear or by reducing the light intensity.

Sunscreens will not protect the areas to which LEVULAN KERASTICK Topical Solution has been applied against sensitivity to light. You must cover or shade these areas from sunlight or sources of bright indoor light.

What are the possible side effects of LEVULAN KERASTICK Topical Solution + Blue Light PDT?

During BLU-U treatment, you will feel tingling, stinging, prickling, or burning of the treated areas. These feelings should improve at the end of BLU-U treatment and should end within 24 hours.

Following BLU-U treatment, the AKs and, to some degree, the surrounding skin,  will redden. Swelling may also occur. These changes should reach a maximum the day after BLU-U treatment. However, these changes are temporary, should improve markedly by the end of the first week, and should be completely resolved by 4 weeks after treatment. Other side effects at the treatment sites may include scaling, itching, and chan