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A Phase II Study of Photodynamic Therapy With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light Using Spot and Broad Area Application and Incubation Times of 1, 2 and 3 Hours for the Treatment of Multiple Actinic Keratoses on the Face or Scalp


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

Thank you

Trial Information

A Phase II Study of Photodynamic Therapy With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light Using Spot and Broad Area Application and Incubation Times of 1, 2 and 3 Hours for the Treatment of Multiple Actinic Keratoses on the Face or Scalp


Inclusion Criteria:



- 6-20 Grade 1/2 AKs on the face or scalp

- a history of AK therapy within the treatment area at least twice in the two years
prior to study entry

Exclusion Criteria:

- Pregnancy

- Grade 3 AKs or atypical AKs (e.g., AK > 1 cm2 in size) within the Treatment Area

- lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated
skin cancers within the Treatment Area

- plans to be exposed to artificial tanning devices or excessive sunlight during the
trial

- Subject is immunosuppressed

- unsuccessful outcome from previous ALA-PDT therapy

- history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or
photodermatosis

- skin pathology or condition which could interfere with the evaluation of the test
product or requires the use of interfering topical or systemic therapy

- skin pathology or condition that could interfere with the evaluation of the test
product or requires the use of interfering topical or systemic therapy

- any condition which would make it unsafe for the subject to participate in this
research study

- 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)

- Subject has;

- an active herpes simplex infection OR

- a history of 2 or more outbreaks within the past 12 months, in the Treatment
Area

- 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:

Complete clearance Rate

Outcome Description:

The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area

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:

CP0105

NCT ID:

NCT01475955

Start Date:

December 2011

Completion Date:

November 2012

Related Keywords:

  • Actinic Keratosis
  • Keratosis
  • Keratosis, Actinic

Name

Location

Virginia Clinical Research IncNorfolk, Virginia  23507
Therapeutics Clinical ResearchLa Jolla, California  92037
Minnesota Clinical Study CenterFridley, Minnesota  55432
Tennessee Clinical Research CenterNashville, Tennessee  37221
DermResearch, Inc.Austin, Texas  78759
Altman Dermatology AssociatesArlington Heights, Illinois  60004
Dermatology Research AssociatesLos Angeles, California  90045
The Indiana Clinical Trials Center, PCPlainfield, Indiana  46168
Oregon Medical Research Center, PCPortland, Oregon  97223
UCSD Dermatology Perlman Ambulatory ClinicLa Jolla, California  92037
Northwest Clinical Trials, Inc.Boise, Idaho  83704
Dermatology Research Center of CincinnatiCincinnati, Ohio  45220
Suzanne Bruce and Associates, P.A.,The Center for Skin ResearchHouston, Texas  77056