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Have you had an organ transplant?
Are you experiencing skin
cancers?
We have a unique study opportunity designed for
organ transplant recipients
who have actinic keratoses (pre-cancerous rough
skin patches) and a history
of frequent non- melanoma skin cancers. |
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Inclusion Criteria including: § Male or female at least 18 years of age. § Be an organ transplant (e.g., kidney, pancreas, liver, lungs,
heart or combination) recipient outpatient taking immunosuppressive
medication. § Females must be post-menopausal, surgically sterile or using a
medically acceptable form of birth control with a negative urine pregnancy
test at the first visit. § Provide written and verbal informed consent. § Have at least three (3) actinic keratosis
lesions in near proximity to each other (either on the top of the forearms or
bald scalp). § Have had two (2) non-melanoma skin cancers in the past 12
months (either on the top of the forearms or bald scalp). § Willing to follow study instructions and return to the clinic
for required visits. Exclusion Criteria including: § Pregnancy. § History of photosensitivity, or sensitivity to Levulan. § You are currently enrolled in another investigational
drug/device study, or have been enrolled into such a study within 30 days
prior to the initiation of this study. § You have used specific topical preparations on the selected
treatment area (your doctor will discuss with you). § You have had systemic retinoid therapy within 6 months
of the initiation of treatment. |
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We are seeking organ transplant recipients taking
anti-rejection medication to participate in a study designed to test
photodynamic therapy (PDT) to treat actinic keratoses
(pre-cancerous rough skin patches). The information gathered from this study will
also assess the potential of PDT in the prevention of non-melanoma skin cancers.
Photodynamic therapy is the use of a topical solution and the application
of a specialized light. If you meet the inclusion and
exclusion criteria, the medical staff will go over your medical history with
you, you will be asked to sign a consent form which explains the details of
the study, you will be given a brief medical exam, as well as having a blood
sample taken. You will be enrolled into
a treatment group receiving Levulan® (the topical
solution) with photodynamic therapy or a treatment group receiving placebo topical
solution with photodynamic therapy. If you have been diagnosed
with actinic keratoses and
have a history of frequent non-melanoma skin cancers, please speak to your
doctor about participating in this research study. Please give us a call today for more information
about this important study. (858) 571-1800 ext. 131 Email us at: jberg@therapeuticsinc.com Study Sites in
the following cities:
This research is sponsored by DUSA Pharmaceuticals, Inc |
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