Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
DUSA Pharmaceuticals, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
6-20 Grade 1/2 AKs on the face or scalp
a history of AK therapy within the treatment area at least twice in the two years prior to study entry
You may not be if
Pregnancy
Grade 3 AKs or atypical AKs (e.g., AK \> 1 cm2 in size) within the Treatment Area
lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
plans to be exposed to artificial tanning devices or excessive sunlight during the trial
Subject is immunosuppressed
unsuccessful outcome from previous ALA-PDT therapy
history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
skin pathology or condition that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
any condition which would make it unsafe for the subject to participate in this research study
currently enrolled in an investigational drug or device study
has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment
known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol)
Subject has;
* an active herpes simplex infection OR
* a history of 2 or more outbreaks within the past 12 months, in the Treatment Area
use of the following topical preparations on the extremities to be treated:
* Keratolytics including urea (greater than 5%), alpha hydroxyacids \[e.g.glycolic acid, lactic acid, etc. greater than 5%\], salicylic acid (greater than 2%) within 2 days of initiation of treatment.
* Cryotherapy within 2 weeks of initiation of treatment
* Retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks of initiation of treatment.
* Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment.
* Two or more ALA PDT treatments in the past 6 months
use of systemic retinoid therapy within 6 months of initiation of treatment.
