Two-Step Levulan® Photodynamic Therapy Offers an Effective Treatment Option
Levulan Photodynamic Therapy using an IPL 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 body. 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 IPL Light Photodynamic Therapy Illuminator.
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 IPL.
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 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: IPL Treatment
After your incubation period, you will receive a IPL light
treatment, which is the second and the final step in the treatment. The IPL
treatment time is approximately 15 minutes.
Important Safety Information
What is Levulan Kerastick used for?
The Levulan Kerastick is indicated for the treatment of minimally
to moderately thick actinic keratoses (Grade 1 or 2) of the face or body.
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.
The benefits of Levulan® PDT Treatment
Levulan is an effective treatment for Grade 1 or 2 AKs of the
face or body. The benefits of Levulan PDT treatment are:
- It is a 2-step treatment procedure:
1. Application of the Levulan Kerastick®
Topical Solution to individual AKs
2. IPL treatment
- Recovery begins right after treatment with the IPL
- 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
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