Levulan® Photodynamic Light Therapy
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 Actinic Keratoses (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. The 2-step process consists of treatment with Levulan® Kerastick Topical Solution, 20%, and the BLU-U® Blue Light Photodynamic Therapy Illuminator (BLU-U®).
​
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 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 can range in color from skin-toned to reddish-brown. They can also vary 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 sunbathe much, years of simple outdoor activities (e.g., going out to the mailbox, sports, etc.) can add up to significant sun exposure. AKs generally appear after the age of 40. Your risk increases if you have one or more of the following risk factors:
-
A history of cumulative sun exposure
-
Fair skin
-
Blonde or red hair, particularly if combined with blue, hazel, or green eyes
-
A tendency to freckle or burn after sun exposure
-
A weakened immune system
What do AKs 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 change in size, shape, and how they are organized. AKs can appear light or dark, the same color as one's skin, tan, pink, red, or a combination of these. They can also vary in size and texture.
Why treat AKs?
AKs are considered 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 the care of a plastic surgeon or dermatologist. Frequent skin examinations are the key to early detection.
Efficacy Proven in Medical Studies
Many patients 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®.
​
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 patients treated with Levulan® had 75% clearance of face lesions and 58% of 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 patients treated with Levulan® had 100% clearance of face lesions and 53% of 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 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 point 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 that destroy the AK cells.
​
Step 1: Application of Levulan® Kerastick Topical Solution
The first step in Levulan® PDT is the application of Levulan® Kerastick Topical Solution, 20%, to the individual AKs on your face or scalp by your dermatologist or other healthcare professional. This solution is an acid that occurs naturally in your body and makes the AKs more sensitive to light. This application prepares the AKs for step 2 of the Levulan® PDT treatment. Once the Levulan® Kerastick Topical Solution is applied, you will be directed to wait the recommended time to allow the solution to penetrate the target cells.
​
Step 2: BLU-U® Treatment
After your incubation period, you will receive a blue light treatment, which is the second and final step in the treatment. The BLU-U® treatment lasts 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 immediately 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 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
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 of 400-450 nm, porphyria, or known allergies to porphyrins, or in patients with known sensitivity to any of the components of 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 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.
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 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.