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

Completed · Phase 2

Conditions studied: Keratosis, Actinic

In brief

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.

Key facts

Study ID

NCT02628236

Run by

DUSA Pharmaceuticals, Inc.

People needed

14

Starts

2016-02-01

Expected to finish

2016-07-01

Last updated by the study team

2017-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 6 Grade 1/2 AKs on one upper extremity AND
• At least 12 Grade 1/2 AKs on the OTHER upper extremity

You may not qualify if…

• 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

Where it is running

• DermResearch, Inc. — Austin, Texas, United States
• J&J Studies, Inc — College Station, Texas, United States

Full record on ClinicalTrials.gov

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