Consent For Levulan Photodynamic Treatment

Levulan (Aminolevulinic acid 20%) is a naturally occurring photosensitizing compound which has been approved by the FDA and Health and Welfare Canada to treat pre-cancerous skin lesions called actinic keratosis. Levulan is applied to the skin and subsequently "activated" by specific wavelengths of light. This process of activating Levulan with light is termed Photodynamic Therapy. The purpose of activating the Levulan is to improve the appearance and reduce acne rosacea, acne vulgaris, sebaceous hyperplasia, decrease oiliness of the skin, and improve texture and smoothness by minimizing pore size. Any precancerous lesions are also simultaneously treated. The improvement of these skin conditions (other than actinic keratosis) is considered an "off-label" use of Levulan.

I understand that Levulan will be applied to my skin for 30-60 minutes. Subsequently, the area will be treated with a specific wavelength of light to activate the Levulan. Following my treatment, I must wash off any Levulan on my skin. I understand that I should avoid direct sunlight for 24 hours following the treatment due to photosensitivity. I understand that I am not pregnant.

Anticipated side effects of Levulan treatment include discomfort, burning, swelling, blistering, scarring, redness and possible skin peeling, especially in any areas of sun damaged skin and pre-cancers of the skin, as well as lightening or darkening of skin tone and spots, and possible hair removal. The peeling may last many days, and the redness for several weeks if I have an exuberant response to treatment.

I consent to the taking of photographs of my face before each treatment session. I understand that I may require several treatment sessions spaced 1-6 weeks apart to achieve optimal results. I understand that I am responsible for payment of this procedure, as it is not covered by health insurance.

I understand that medicine is not an exact science, and that there can be no guarantees of my results. I am aware that while some individuals have fabulous results, it is possible that these treatments will not work for me. I understand that alternative treatments include topical medications, oral medications, cryosurgery, excisional surgery, and doing nothing.

I have read the above information and understand it. My questions have been answered satisfactorily by the doctor and his staff. I accept the risks and complications of the procedure. By signing this consent form I agree to have one or more Levulan treatments.

Name Signature

Date Witness

Fig. 6.15. Informed consent for ALA-PDT

Fig. 6.16. Informed consent for laser/light therapy for psoriasis and disorders of hypopigmentation

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