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

This study has been terminated.
(Orphan Drug Designation for this indication not granted)
Sponsor:
Information provided by (Responsible Party):
DUSA Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00865878
First received: March 18, 2009
Last updated: October 20, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Actinic Keratoses
Skin Neoplasms
Drug: Aminolevulinic Acid
Other: Vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Evaluator-Blinded, Parallel Group Comparison of PDT With Levulan Topical Solution + Blue Light vs Levulan Topical Solution Vehicle + Blue Light for the Treatment of AK and Reduction of New NMSC in Organ Transplant Recipients

Resource links provided by NLM:


Further study details as provided by DUSA Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Number of Skin Cancers within the Treatment Area [ Time Frame: entire study ] [ Designated as safety issue: No ]
  • AK Lesions Counts/Surface Area [ Time Frame: Visits 1,3,5,7,9,11,13,15,17,19 ] [ Designated as safety issue: No ]
  • Investigator Global Assessment [ Time Frame: Visits 1,3,5,7,9,11,13,15,17,19 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subject Acceptability of Treatment [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • Tolerability Parameters [ Time Frame: Each Visit ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: May 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
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.
Other Name: Levulan
Placebo Comparator: 2
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
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.

Detailed Description:

This is a Phase II multicenter, randomized, evaluator-blinded, vehicle-controlled, parallel group study of photodynamic therapy in organ transplant recipient subjects for treatment of AK and the reduction of new NMSC.

Subjects will be randomized to one of the following two treatment groups (1:1) to receive topical Levulan® Kerastick® containing 20% aminolevulinic acid HCL (ALA, active study drug) or the Kerastick® containing vehicle ingredients only (VEH).

  • Group 1 will have ALA applied to the entire scalp OR both forearms 90 +/- 30 minutes prior to BLUE light treatment for 16 minutes 40 seconds
  • Group 2 will have VEH applied to the entire scalp OR both forearms 90 +/- 30 minutes prior to BLUE light treatment for 16 minutes 40 seconds

Treatment Area (scalp or both forearms) must have had at least 2 NMSC in the past 12 months, and must include a continuous 25 cm2 Target Area containing a minimum of 3 AKs, to be eligible for treatment

Each subject may receive up to nine treatments. The initial four (4) ALA-PDT/VEH-PDT treatments will be given at 4-5 week intervals, with the remaining five (5) treatments given every 6 +/-1 weeks. Post-treatment follow-up visit will be scheduled to occur 4 weeks after the subject's final PDT.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Subject has provided written and verbal informed consent.
  3. Subject has at least 3 actinic keratosis lesions in a continuous 25 cm2 Target Area within the selected anatomic treatment site (scalp or forearm).
  4. 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
  5. Subject is currently receiving standard active pharmacologic immunosuppression
  6. Subject is willing to comply with study instructions and return to the clinic for required visits.
  7. Subject has Fitzpatrick skin type I-IV.

Exclusion Criteria:

  1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
  2. Subject has a history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis.
  3. 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.
  4. Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
  5. 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.
  6. 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.
  7. Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
  8. 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.
  9. Subject has a known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol).
  10. 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.
  11. 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.
    • 5-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.
    • Two or more ALA PDT treatments in the past 6 months
  12. Subject has used systemic retinoid therapy within 6 months of the initiation of treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00865878

Locations
United States, California
University of California, Irvine
Irvine, California, United States, 92697
University of California, San Francisco
San Francisco, California, United States, 94115
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, New York
The Mount Sinai Medical Center
New York, New York, United States, 10029
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37204
Sponsors and Collaborators
DUSA Pharmaceuticals, Inc.
Investigators
Study Director: Stuart L Marcus, MD, PhD Sponsor GmbH
  More Information

No publications provided

Responsible Party: DUSA Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00865878     History of Changes
Other Study ID Numbers: DUSA-CP0104
Study First Received: March 18, 2009
Last Updated: October 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by DUSA Pharmaceuticals, Inc.:
Actinic Keratoses
Skin Neoplasms
Photodynamic Therapy
Transplants

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Neoplasms
Skin Neoplasms
Neoplasms by Site
Precancerous Conditions
Skin Diseases
Aminolevulinic Acid
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014