Photodynamic Therapy Procedure Consent
Aminolevulinic Acid 20% (Levulan) is a naturally occurring photosensitizing compound, which has been approved by the FDA to treat precancerous lesions called actinic keratoses. This treatment has also been used in numerous off label uses such as acne, photorejuvenation, wrinkle and dark spot correction, and skin cancer treatment.
The Aminolevulinic Acid is applied to the skin for a period of time ranging from 1-4 hours after cleansing with acetone. The application area is placed under a blue light source for approximately 17 minutes. Alternatively, a laser source may be used. The light source activates the Aminolevulinic Acid and results in destruction of abnormal (precancerous) cells and oil glands.
Off label uses are typically NOT covered under any insurance.
Prior to treatment, the area to be treated may or may not be anesthetized with a topical numbing cream. Please let us know if you are taking or have recently taken any medications, including cold sore medications.
This treatment is not recommended if you are pregnant or planning on becoming pregnant.
Following your treatment, you may experience pain, swelling and redness, similar to a mild-sunburn, for the first several days. You are advised to avoid sun exposure for 48 hours after the procedure.
Risks of this procedure include, but are not limited to, the following:
Pain – Some people may feel some pain with this treatment, similar to snapping the skin with a rubber band. Stinging or sharp pain may be present after the procedure and throughout the healing process.
Redness – Laser treatment will cause redness of the area. The redness may be present for weeks to months.
Swelling – Swelling will be present after the procedure and should likely resolve after 1-2 weeks.
Pigmentary Changes – The treated area may heal with altered pigmentation (either lighter or darker skin). This occurs most often with darker colored skin and after exposure of the area to sun. You may have experienced this type of reaction before and noticed it with minor cuts or abrasions. The treated area must be protected from exposure to the sun (sunscreen for 4 weeks after treatment) to minimize the possibility of such changes, although pigmentary changes may occur despite sunavoidance. While these pigmentary changes usually fade in three to six months, in some cases, the pigment change is permanent.
Scarring – There is a risk of scarring with this procedure at any time during the healing process. The scarring may be discolored and may be permanent.
Bleeding – Bleeding is unusual with any of these laser treatments unless blistering or scabbing occurs. In that event, you may continue to have some oozing and bleeding for 1-3 days after the procedure.
Blistering – The laser procedure may produce heating in the upper layers of the skin resulting in blister formation. The blisters should go away within two to four days. Scarring or discoloration may result from any blister formation.
Scabbing – A scab may be present after a blister forms. The scabbing will disappear during the natural wound healing process of the skin. Scarring or discoloration may result from any scab formation.
Infection – An infection of the wound is always possible. Any blistering or bleeding must be dressed with an antibiotic ointment and covered. Any infection could last seven to ten days and could lead to scarring.
Peeling – Peeling of the skin may occur in the treated areas, especially those areas with precancerous lesions.
Activation of the Cold Sore Virus – You may get an eruption of the cold sore virus around your lips or in the treated crusted or peeling areas. This infection may be severe and lad to significant illness, scarring, or discoloration.
Failure to Achieve Desired Results – It is very possible that this procedure may fail to achieve your desired results. Strict adherence to the pre-op and post-op instructions is essential. You may need to repeat your treatments to achieve the desired results.
I, the undersigned, have read and understand the information contained within this consent form. My signature indicates that I have read and understand the information in the consent. I hereby release the dermatology office and my physician from all liability associated with this procedure. Furthermore, my signature below indicates my consent to the treatment described and my agreement to comply with the requirements placed on me by this consent form.
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