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A Phase II Study of Photodynamic Therapy (PDT)With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities


Phase 2
18 Years
N/A
Not Enrolling
Both
Keratosis, Actinic

Thank you

Trial Information

A Phase II Study of Photodynamic Therapy (PDT)With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Lesion Clearance Rate

Outcome Description:

Clearance rate for all lesions

Outcome Time Frame:

Week 12

Safety Issue:

No

Principal Investigator

Stuart Marcus, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

DUSA Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

CP0106

NCT ID:

NCT01458587

Start Date:

November 2011

Completion Date:

July 2012

Related Keywords:

  • Keratosis, Actinic
  • Actinic keratosis
  • Keratosis
  • Keratosis, Actinic

Name

Location

Therapeutics Clinical Research La Jolla, California  92037
Park Avenue Dermatology, PA 1543 Kingsley Ave, Bldg 1 and 16 Orange Park, Florida  32073
DermResearch, Inc Austin, Texas  78759