Informed Consent Levulan® Photodynamic Therapy
Description of Treatment:
A brief medical history will be taken and an examination of your skin will be performed.
This area may be photographed.
You will avoid picking or scratching the area, and you will also avoid sun exposure and tanning beds,
which can cause skin to heal abnormally.
If it is appropriate a biopsy will be sent to the lab for a pathologist to look at under a microscope. You will receive a separate bill
from the pathology lab if this is done.
One or several small wounds will be created by the treatment
that may leave a scar and will require time to heal.
Targeted therapy destroys Grade I or II Actinic Keratoses
®
Levulan PDT is a 2-part treatment: . Application of Levulan
®
Kerastick Topical Solution, 20%
®
2. BLU-U Blue Light Photodynamic Illumination
* Highly targeted spot treatment allows precise therapeutic
control
Important Safety Information
Levulan® Kerastick® 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.
Application of Levulan® Kerastick® should involve either
scalp or face lesions, but not both simultaneously. Levulan®
Kerastick® should not be applied to the periorbital area or allowed to contact ocular or mucosal surfaces. Contraindicated
in patients with cutaneous photosensitivity at wavelengths of 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. It is possible that concomitant
use of other known photosensitizing agents might increase the photosensitivity reaction of actinic keratoses treated with
the Levulan® Kerastick®. Patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor
light prior to blue light treatment. Exposure may result in a stinging and/or burning sensation and may cause erythema or
edema of the lesions. Patients should protect treated lesions from the sun by wearing a wide-brimmed hat or similar head
covering of light-opaque material. Sunscreens will not protect against photosensitivity reactions caused by visible light.
Transient local symptoms of stinging and/or burning, itching, erythema, and edema were observed in all clinical studies.
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. However, less than 3% of patients discontinued light treatment due to stinging and/or burning. During
light treatment, both patients and medical personnel should be provided with blue blocking protective eyewear, as
specified in the BLU-U operating instructions to minimize ocular exposure.
Confidentiality
Medical information associated with treatment will become part of your medical record, and will be stored in the doctor’s
file under restricted access.
Contact Person / PhysicianIf you have any questions about this treatment, or treatment related injury, please contact the
re*be Skin Clinic, Dr. Ronald Kolegraff or their staff at 1008 East View Ave. Okoboji, Iowa 51355 phone (712) 332-
6001.
Client Signature: I authorize the taking of clinical photographs and their use for future treatments at this clinic.
My photographs in addition may be used for:
scientific purposes yes no
in publications yes no
presentations or seminars yes no
presented to the internet yes no
I confirm that the staff at the re*be Skin Clinic has explained to me the purpose of the treatment, the procedures I will undergo
and the possible risks and discomforts as well as benefits that I may experience. Alternatives to this treatment have been
discussed. I have read and understand the consent form. I understand the information given to me and voluntarily agree to
pursue this course of treatment.
_______________________________
Clients Name (Print)
_____________________
Client’s Signature (Date )ALA Consent.doc