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.
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
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.
Study Sites in
the following cities:
Irvine, CA (UCI); and San Francisco, CA (UCSF)
This research is sponsored by DUSA Pharmaceuticals, Inc