Status:
COMPLETED
Maximal Use Systemic Exposure (MUSE) Study of Levulan Kerastick
Lead Sponsor:
DUSA Pharmaceuticals, Inc.
Conditions:
Keratosis, Actinic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the potential for systemic exposure of aminolevulinic acid (ALA) when applied topically under occlusion, in a maximal use setting in patients with multiple act...
Eligibility Criteria
Inclusion
- At least 6 Grade 1/2 AKs on one upper extremity AND
- At least 12 Grade 1/2 AKs on the OTHER upper extremity
Exclusion
- Pregnancy
- 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
- Body Mass Index (BMI) \> 32.0 kg/m2
- skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
- significant blood loss within 60 days or donated blood/plasma within 72 hours prior to Visit 2 (Baseline)
- tested positive at screening for human immunodeficiency virus (HIV) or was known to be seropositive for HIV
- a history of lead poisoning or a history of a significant exposure to lead or a screening lead level above 6μg/dl
- tested positive at screening for hepatitis B surface antigen, hepatitis C antibody or had a history of a positive result
- positive drug screen at Screening
- Screening safety labs are clinically significant in the opinion of the investigator
- major surgery within 30 days prior to Visit 2 (Baseline) or plans to have surgery during the study
- Subject is immunosuppressed
- 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 Visit 2 (Baseline)
- known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol)
- 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
- use of systemic retinoid therapy within 6 months of initiation of treatment
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT02281136
Start Date
December 1 2014
End Date
April 1 2015
Last Update
January 13 2017
Active Locations (3)
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1
Therapeutics Clinical Research
San Diego, California, United States, 92123
2
Shideler Clinical Research Center
Carmel, Indiana, United States, 46032
3
DermResearch, Inc.
Austin, Texas, United States, 78759