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 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
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
- 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.
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
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
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
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.