Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK)

NCT ID: NCT01458587

Last Updated: 2013-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-07-31

Brief Summary

The purpose of this study is to determine if Levulan PDT is safe and effective in the treatment of actinic keratoses on the upper arms and hands.

Conditions

Keratosis, Actinic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ALA

Group Type: EXPERIMENTAL

Aminolevulinic Acid PDT (ALA)

Intervention Type: DRUG

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

Vehicle

Group Type: PLACEBO_COMPARATOR

Vehicle PDT (VEH)

Intervention Type: DRUG

Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light

Interventions

Aminolevulinic Acid PDT (ALA)

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

Intervention Type: DRUG

Vehicle PDT (VEH)

Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light

Intervention Type: DRUG

Other Intervention Names

Levulan Kerastick

Eligibility Criteria

Inclusion Criteria

• At least 4 Grade 1/2 AKs on each 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
• skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
• Subject is immunosuppressed
• unsuccessful outcome from previous ALA-PDT therapy
• 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 the initiation of treatment
• 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.
• Two or more ALA PDT treatments in the past 6 months
• 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

Therapeutics Clinical Research

San Diego, California, United States

Park Avenue Dermatology, PA

Orange Park, Florida, United States

DermResearch, Inc

Austin, Texas, United States

Countries

United States

Other Identifiers

CP0106

Identifier Type: -

Identifier Source: org_study_id