Maximal Use Systemic Exposure Study of Levulan Kerastick (MUSE 2)

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the potential for systemic exposure of aminolevulinic acid (ALA) and protoporphyrin IX (PpIX) when applied topically under occlusion, in a maximal use setting in patients with multiple actinic keratoses (AK) involving the upper extremities.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: DUSA Pharmaceuticals, Inc.
• Treatments: Aminolevulinic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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

• 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