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

NCT ID: NCT02628236

Last Updated: 2017-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-07-31

Brief 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.

Conditions

Keratosis, Actinic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

ALA

20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment

Group Type: EXPERIMENTAL

Aminolevulinic Acid (ALA)

Intervention Type: DRUG

20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light

BLU-U

Intervention Type: DEVICE

10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2

Interventions

Aminolevulinic Acid (ALA)

20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light

Intervention Type: DRUG

BLU-U

10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2

Intervention Type: DEVICE

Other Intervention Names

Levulan Kerastick; Blue Light Photodynamic Therapy (PDT)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DUSA Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stuart Marcus, MD, PhD

Role: STUDY_DIRECTOR

DUSA Pharmaceuticals, Inc.

Locations

DermResearch, Inc.

Austin, Texas, United States

J&J Studies, Inc

College Station, Texas, United States

Countries

United States

Other Identifiers

CP0113

Identifier Type: -

Identifier Source: org_study_id