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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Actinic Keratoses, Skin Neoplasms

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Trial Information

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


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.


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.

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:

Number of Skin Cancers within the Treatment Area

Outcome Time Frame:

entire study

Safety Issue:

No

Principal Investigator

Stuart L Marcus, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Sponsor GmbH

Authority:

United States: Food and Drug Administration

Study ID:

DUSA-CP0104

NCT ID:

NCT00865878

Start Date:

May 2009

Completion Date:

September 2011

Related Keywords:

  • Actinic Keratoses
  • Skin Neoplasms
  • Actinic Keratoses
  • Skin Neoplasms
  • Photodynamic Therapy
  • Transplants
  • Neoplasms
  • Skin Neoplasms
  • Keratosis
  • Keratosis, Actinic

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
University of California, San FranciscoSan Francisco, California  94143
Tufts Medical CenterBoston, Massachusetts  02111
University of MiamiMiami, Florida  33136
University of California, IrvineOrange, California  92868
The Mount Sinai Medical CenterNew York, New York  10029