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Photodynamic Therapy With Levulan® Topical Solution And Blue Light +/- Topical Retinoid Pre-Treatment In The Treatment Of Dorsal Hand/Forearm Actinic Keratoses

18 Years
Not Enrolling

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Trial Information

Photodynamic Therapy With Levulan® Topical Solution And Blue Light +/- Topical Retinoid Pre-Treatment In The Treatment Of Dorsal Hand/Forearm Actinic Keratoses

Subjects will be randomized such that their RIGHT dorsal hand/forearm will receive one of
the following two treatments with the subject's LEFT dorsal hand/forearm receiving the other
treatment; Treatment 1 will include pre-treatment of the dorsal hand/forearm with Tazorac
0.1% gel BID for one week, followed by ALA applied to the entire dorsal hand/forearm 60
minutes prior to BLUE light treatment for 16 minutes 40 seconds Treatment 2 will have ALA
applied to the entire dorsal hand/forearm and occluded for 60 minutes prior to BLUE light
treatment for 16 minutes 40 secondsNote: ALA will be applied to individual dorsal
hand/forearm actinic keratoses (AK) lesions followed by broad area application over the
entire dorsal hand/forearm surface. The treatment area on the side NOT pre-treated with
Tazorac will then be occluded using plastic wrap for 60 minutes. The treatment area of the
dorsal hand/forearm is defined as the extensor surface of the hand/forearm between the elbow
and the base of the fingers (the fingers are NOT included in the treatment area).

Inclusion Criteria:

1. Subject is male or non-pregnant female over the age of 18 years. 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 four (4) AK lesions (Grade 1 or 2) on each Treatment Area (dorsal
forearm/hand surface), with at least 3 of these lesions in a continuous 25 cm2 Target Area
on the hand or forearm.

4. Subject is willing to comply with study instructions and return to the clinic for
required visits.

Exclusion Criteria:

- 1. Subject is pregnant, lactating, or is planning to become pregnant during the

2. Subject has a history of cutaneous photosensitization, porphyria, hypersensitivity
to porphyrins or photodermatosis or any condition with associated immunosuppression
(e.g. HIV, systemic malignancy, etc.).

3. Subject has any skin pathology or condition that could interfere with the
evaluation of the test product or requires the use of interfering topical or systemic

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 or device study. 6.
Subject has received an investigational drug or been treated with an investigational
device within 30 days prior to the initiation of treatment (baseline).

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 a known sensitivity to one or more of the components of Tazorac
(tazarotene, benzyl alcohol, ascorbin acid, butylated hydroxyanisole, butylated
hydroxytoluene, carbomer 934P, edentate disodium, hexylene glycol, poloxamer 407,
polyethylene glycol 400, polysorbate 40, tromethamine).

11. Subject has the need to be exposed to artificial tanning devices or excessive
sunlight during the trial.

12. Subject has used photosensitizing drugs, (e.g. thiazides, tetracyclines,
fluoroquinolones, phenothiazines, sulfonamides, etc) within a timeframe where
photosensitization from these drugs may still be present, or has the need to use them
during the trial.

13. Subject has used any of the following topical preparations on the dorsal
hands/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. · Retinoids, including tazarotene,
adapalene, tretinoin, retinol, within 4 weeks of the initiation of treatment.·
5-FU, cryotherapy, diclofenac, imiquimod or other treatments for AK within 8 weeks of
initiation of treatment.· Microdermabrasion, laser ablative treatments or chemical
peels within 8 weeks of the initiation of treatment. · ALA-PDT within 6 months of
initiation of treatment.

14. Subject has used any of the following systemic medications: · Immuno-suppressants
including steroids, chemotherapy, etc. within 3 months of the initiation of
treatment· Retinoid therapy within 6 months of the initiation of treatment.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in lesion counts in 25 cm2 Target Area relative to Baseline. Tolerability of treatment, local and systemic adverse events.

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Barry Galitzer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roger H. Stewart MD PA


United States: Institutional Review Board

Study ID:




Start Date:

January 2010

Completion Date:

November 2010

Related Keywords:

  • Actinic Keratoses
  • HAND
  • Keratosis
  • Keratosis, Actinic
  • Ichthyosis
  • Keratoacanthoma



Roger Stewart MD PA Fort Lauderdale, Florida  33308