Maximal Use Systemic Exposure (MUSE) Study of Levulan Kerastick

Dusa Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Keratosis, Actinic

Treatments: Drug: Aminolevulinic Acid (ALA); Device: BLU-U

Study type: Interventional

Funder types: Industry

Identifiers

NCT02281136

CP0110

Details and patient eligibility

About

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 actinic keratoses (AK) involving the upper extremities.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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

Trial design

29 participants in 1 patient group

ALA

Experimental group

Description:

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

Treatment:

Device: BLU-U

Drug: Aminolevulinic Acid (ALA)