NCT01458587

Trial name or title	A Phase II Study of Photodynamic Therapy With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities
Methods	This was a multicentre, randomised, double‐blind, placebo‐controlled, parallel‐group study.
Participants	Inclusion criteria of the trial Men and women Aged 18 years and older Anatomical location: upper extremities > 4 grade I/II actinic keratoses on each upper extremity Exclusion criteria of the trial Pregnancy History of cutaneous photosensitisation, 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 Immunosuppressed Unsuccessful outcome from previous ALA‐PDT therapy Currently enrolled in an investigational drug or device study or 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) Treatment on the extremities to be treated as follows: within 2 days with keratolytics including urea (greater than 5%), alpha hydroxy acids [e.g. glycolic acid, lactic acid, etc, greater than 5%], or salicylic acid (greater than 2%) within 2 weeks with cryotherapy within 4 weeks with retinoids, including tazarotene, adapalene, tretinoin, or retinol within 8 weeks with microdermabrasion, laser ablative treatments, ALA‐PDT, chemical peels, 5‐FU, diclofenac, imiquimod, or other topical treatments for actinic keratosis within 6 months with 2 or more ALA PDT treatments or systemic retinoid therapy Demographics 64 participants
Interventions	Intervention A: 3 hours 20% ALA‐blue light PDT Control intervention B: 3 hours vehicle‐blue light PDT
Outcomes	Primary outcome of the trial 1) Clearance rate for baseline grade I/II lesions at week 12 Secondary outcomes of the trial 1) Clearance rate for all baseline lesions at weeks 8 and 12 2) Clearance rate for baseline grade I/II lesions at week 8 3) Per cent change in total actinic keratoses at weeks 8 and 12 4) Participant complete clearance at weeks 8 and 12 5) Participant complete clearance excluding grade III lesions at weeks 8 and 12 6) Participant partial (> 75%) clearance at weeks 8 and 12 7) Participant satisfaction score 8) Changes in pigmentation (hypo and hyper) at 2, 8, and 12 weeks after PDT 9) Local skin reactions during PDT (stinging/burning); 5 minutes after PDT (erythema, edema); and 2, 8, and 12 weeks after PDT (erythema, edema, stinging/burning, scaling/dryness, oozing/vesiculation/crusting)
Starting date	November 2011
Contact information	Jim Berg (jberg@therapeuticsinc.com) Dan Piacquadio, MD (danp@therapeuticsinc.com)
NCT	NCT01458587
Notes	This study is recruiting, and the last update was in November 2011 (April 2012).