ALA-PDT Versus Vehicle PDT for Treatment of AK and Reduction of New NMSC in Solid Organ Transplant Recipients

NCT00865878 | Terminated Phase 2

• 1 other identifier: DUSA-CP0104
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to determine and compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) versus vehicle PDT (VEH-PDT) in the treatment of actinic keratoses (AK) and reduction of new non-melanoma skin cancer (NMSC) of the scalp or both forearms in solid organ transplant recipient subjects receiving chronic immunosuppressive therapy.

Conditions

Actinic Keratoses; Skin Neoplasms

Keywords

Actinic Keratoses; Skin Neoplasms; Photodynamic Therapy; Transplants

Outcome Measures

Primary Outcomes (3)

• Number of Skin Cancers within the Treatment Area

  entire study

• AK Lesions Counts/Surface Area

  Visits 1,3,5,7,9,11,13,15,17,19

• Investigator Global Assessment

  Visits 1,3,5,7,9,11,13,15,17,19

Secondary Outcomes (2)

• Subject Acceptability of Treatment

  End of Study

• Tolerability Parameters

  Each Visit

Study Arms (2)

1

ACTIVE COMPARATOR

Topical Levulan Kerastick containing 20% aminolevulinic acid HCL (ALA) will be applied to the entire scalp OR both forearms 90 +/- 30 minutes prior to blue light treatment for 16 minutes and 40 seconds.

Drug: Aminolevulinic Acid

2

PLACEBO COMPARATOR

Kerastick containing vehicle ingredients only (VEH) will be applied to the entire scalp OR both forearms 90 +/- 30 minutes prior to blue light treatment for 16 minutes 40 seconds.

Other: Vehicle

Interventions

Aminolevulinic Acid DRUG

20% aminolevulinic acid HCL (ALA) applied topically for 90 +/- 30 minutes prior to treatment with 10 j/cm2 blue light. Up to nine (9) ALA-PDT treatments will be given: The initial four (4) treatments will be given at 4-5 week intervals, with the remaining five (5) treatments given every 6 +/-1 weeks.

Also known as: Levulan

1

Vehicle OTHER

Vehicle ingredients only (VEH) applied topically for 90 +/- 30 minutes prior to treatment with 10 j/cm2 blue light. Up to nine (9) VEH-PDT treatments will be given: The initial four (4) treatments will be given at 4-5 week intervals, with the remaining five (5) treatments given every 6 +/-1 weeks.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is male or non-pregnant female organ transplant (kidney, liver, pancreas, lungs, heart or combinations thereof) recipient outpatient 18 years of age or older. Females must be post-menopausal, surgically sterile or using a medically acceptable form of birth control, with a negative urine pregnancy test at the Baseline visit.
• Subject has provided written and verbal informed consent.
• Subject has at least 3 actinic keratosis lesions in a continuous 25 cm2 Target Area within the selected anatomic treatment site (scalp or forearm).
• Subject has a history of a minimum of 2 NMSC on the treatment area of interest (scalp OR both forearms) in the past 12 months
• Subject is currently receiving standard active pharmacologic immunosuppression
• Subject is willing to comply with study instructions and return to the clinic for required visits.
• Subject has Fitzpatrick skin type I-IV.

You may not qualify if:

• Subject is pregnant, lactating, or is planning to become pregnant during the study.
• Subject has a history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis.
• Subject has any skin pathology or condition, in the investigator's opinion, that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy.
• Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
• Subject is currently enrolled in an investigational drug (including experimental immunosuppressive agents containing new chemical entities) or device study. Novel combinations of and alternative dosing regimens of approved immunosuppressive agents are allowed.
• Subject has received an investigational drug (including experimental immunosuppressive agents containing new chemical entities) or been treated with an investigational device within 30 days prior to the initiation of treatment (baseline). Novel combinations of and alternative dosing regimens of approved immunosuppressive agents are allowed.
• Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
• Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
• Subject has a known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol).
• Subject has active recurrent herpes simplex labialis infection in the treatment area with an outbreak within the last 12 months and will not be placed on antiviral prophylaxis as specified in the protocol.
• Subject has used any of the following topical preparations on the selected Treatment Area (scalp OR both forearms):
• 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.
• FU, cryotherapy, diclofenac, imiquimod or other treatments for AK within 2 weeks of initiation of treatment
• Retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks of the initiation of treatment.
• Microdermabrasion, laser ablative treatments, ALA-PDT or chemical peels within 8 weeks of the initiation of treatment.

Sponsors & Collaborators

• DUSA Pharmaceuticals, Inc.: lead

Study Sites (7)

University of California, Irvine

Irvine, California, 92697, United States

Location

University of California, San Francisco

San Francisco, California, 94115, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

The Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37204, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic; Skin Neoplasms

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Stuart L Marcus, MD, PhD

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2009
• First Posted: March 19, 2009
• Study Start: May 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 21, 2011

Record last verified: 2011-10

Locations

US (7)