Levulan Kerastick (Aminolevulinic Acid HCI)

What are Actinic Keratoses?
Actinic Keratoses (AKs) are rough-textured, dry, scaly patches on the skin caused by excessive exposure to ultraviolet (UV) light, such as sunlight. They are often referred to as "sun spots" and they occur most frequently on sun exposed areas such as the face, scalp, ears, neck, hands and arms. They form on the outermost layer of skin and they can range in color from skin toned to reddish brown. They can also range in size from as small as a pinhead to larger than a quarter. More than 10 million Americans have AK lesions, with the majority occurring primarily in fair skinned individuals.

Who gets AKs?
AKs develop as the result of years of sun exposure. Because it accumulates over time, it is your lifetime exposure that increases your risk. Even if you didn't sun-tan much, years of just doing simple tasks outside (e.g. going out to the mailbox, sports, etc.) all add up to a significant amount of sun exposure. Because AKs take a long time to develop, they generally appear after the age of 40. Your risk of developing AKs increases if you have one or more of the risk factors. These risk factors include:

• A history of cumulative sun exposure
• Fair skin
• Blonde 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

What do AK's look like?
Approximately 90% of the outermost layer of skin (epidermis) is made up of tough walled cells called keratinocytes. It is these cells that give the skin its texture. When keratinocytes are exposed to years of sunlight, cell damage can occur. These cells then change in size, shape, as well as the way they are organized. AKs may range in appearance. They can be light or dark, the same color as one's skin, tan, pink, red, or even a combination of these. They can also range in size and texture.

Why treat AKs?
AKs are considered to be the first step in the development of skin cancer. They have the potential to progress to squamous cell carcinoma which is generally not life threatening if detected and treated early. In most cases, when AKs and all types of skin cancers are caught in the early stages, they are treatable and curable. That is why it is so important for individuals with AKs to be under a dermatologist's care. Frequent skin examinations are the key to early detection.

Two-Step Levulan® Photodynamic Therapy Offers an Effective Treatment Option
Levulan Photodynamic Therapy using the BLU-U® Blue Light Photodynamic Therapy Illuminator is an advanced 2-step treatment for minimally to moderately thick Grade 1 or 2 AKs (AKs that have not yet become enlarged and thick) of the face or scalp. This therapy is unique because it uses a light activated drug therapy to destroy AKs. The 2-step process consists of treatment with Levulan Kerastick Topical Solution, 20% and the BLU-U Blue Light Photodynamic Therapy Illuminator (BLU-U).

Efficacy proven in medical studies
Many of the patients participating in the studies experienced 75-100% clearance of Grade 1 or 2 AKs eight weeks after treatment with Levulan Kerastick Topical Solution and BLU-U.

Percent of patients who had a 75-100% response at 8 weeks

At 8 weeks…

• 75% clearance of AK lesions was experienced by 77% of patients treated with Levulan PDT vs 18% of vehicle-treated patients (p<0.001)

• 83% of the patients treated with Levulan had 75% clearance of face lesions and 58% of the patients had 75% clearance of scalp lesions.

• 100% clearance of AK lesions was experienced by 66% of patients treated with Levulan PDT vs 11% of vehicle-treated patients (p<0.001)

• 70% of the patients treated with Levulan had 100% clearance of face lesions and 53% of the patients had 100% clearance of scalp lesions.

Many patients rated the cosmetic response as good to excellent
Based on the combined results of two medical studies, 94% of patients treated with Levulan PDT and BLU-U rated the cosmetic response as good to excellent.

Additionally, no scarring was reported during the medical studies. The most common side effects experienced by patients in these medical studies included scaling/crusting, hypo/hyper-pigmentation, itching, stinging, and/or burning, redness and swelling. Severe stinging and/or burning at one or more lesions being treated was reported by at least 50% of patients at some time during treatment.

How does Levulan PDT work?
When Levulan Kerastick Topical Solution is applied to Grade 1 or 2 AKs, the solution is 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, this light causes reactions which destroy the AK cells.

Step 1: Application of the Levulan Kerastick Topical Solution
The first step in Levulan PDT is the application of the Levulan Kerastick Topical Solution, 20% to the individual AKs on your face or scalp by your dermatologist or other health care professional. This solution is an acid that occurs naturally in your body. It makes the AKs more sensitive to light. This application prepares the AKs for step 2 in the Levulan PDT treatment. Once the Levulan Kerastick Topical Solution is applied to the AKs, your doctor will direct you to wait the recommended time in order to allow the solution to penetrate the target cells we mentioned earlier.

Step 2: BLU-U Treatment
After your incubation period, you will receive a blue light treatment, which is the second and the final step in the treatment. The BLU-U treatment time is 16 minutes and 40 seconds.

The benefits of Levulan® PDT Treatment
Levulan is an effective treatment for Grade 1 or 2 AKs of the face or scalp. The benefits of Levulan PDT treatment are:

• Recovery begins right after treatment with BLU-U®
• Levulan PDT treatment targets and destroys only the damaged AK cells
• 94% of patients treated with Levulan PDT rated their response to treatment as good to excellent
• Complete response demonstrated in a high percentage of patients
• High clearance maintained through 12 months
• Low downtime
• No reports of scarring to date
• Treatment is reimbursed by Medicare and many insurance companies

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Important Safety 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 (Grade 1 or 2) 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 48 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.