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Keep this study
Lead
DUSA Pharmaceuticals, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Four to fifteen Grade 1/2 actinic keratosis lesions (AKs) on the face OR balding scalp
You may not be if
Pregnancy
grade 3 and/or atypical \>1cm AKs within Treatment Area and/or more than 15 AKs of any Grade within the Treatment Area
history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
Subject is immunosuppressed
unsuccessful outcome from previous ALA-PDT therapy
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)
has active herpes simplex infection in the Treatment Area OR a history of 2 or more outbreaks within past 12 months, in the Treatment Area
use of the following topical preparations on the extremity 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.
* Curettage or Cryotherapy within 2 weeks of initiation of treatment
* Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks of initiation of treatment.
* Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment.
use of systemic retinoid therapy within 6 months of initiation of treatment.
Clareo Health | Phase 3 Study of Levulan With New Blue Light for AK on the Face or Scalp