Clinical trial NCT01458587: Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK)
Official title: A Phase II Study of Photodynamic Therapy (PDT)With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Keratosis, Actinic
Keywords: Actinic keratosis
Lead sponsor: DUSA Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-10-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if Levulan PDT is safe and effective in the treatment of actinic keratoses on the upper arms and hands.


Eligibility criteria: Inclusion Criteria:

* At least 4 Grade 1/2 AKs on each upper extremity

Exclusion Criteria:

* Pregnancy
* history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
* lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
* skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
* Subject is immunosuppressed
* unsuccessful outcome from previous ALA-PDT therapy
* 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)
* 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.

Primary outcomes:
measure: Lesion Clearance Rate
timeFrame: Week 12
Secondary outcomes:
measure: Lesion Clearance Rate
timeFrame: Week 8
measure: Complete Clearance Rate
timeFrame: Week 8
measure: Complete Clearance Rate
timeFrame: Week 12
measure: Partial Clearance Rate
timeFrame: Baseline and Week 8
measure: Partial Clearance Rate
timeFrame: Baseline and Week 12
measure: Subject Satisfaction Score
timeFrame: Week 12
measure: Hyperpigmentation at Baseline
timeFrame: Baseline
measure: Hyperpigmentation at Visit 3
timeFrame: 2 weeks after PDT #1
measure: Hyperpigmentation at Visit 4
timeFrame: 8 weeks after PDT #1
measure: Hyperpigmentation at Visit 5
timeFrame: 12 weeks after PDT #1
measure: Hypopigmentation at Baseline
timeFrame: Baseline
measure: Hypopigmentation at Visit 3
timeFrame: 2 Weeks after PDT #1
measure: Hypopigmentation at Visit 4
timeFrame: 8 Weeks after PDT #1
measure: Hypopigmentation at Visit 5
timeFrame: 12 Weeks after PDT #1
measure: Erythema at Baseline
timeFrame: Baseline
measure: Erythema Post-Light Treatment
timeFrame: 5 Minutes after PDT #1
measure: Erythema at Visit 3
timeFrame: 2 Weeks after PDT #1
measure: Erythema at Visit 4
timeFrame: 8 Weeks after PDT #1
measure: Erythema at Visit 5
timeFrame: 12 Weeks after PDT #1
measure: Edema at Baseline
timeFrame: Baseline
measure: Edema Post-Light Treatment
timeFrame: 5 Minutes after PDT #1
measure: Edema at Visit 3
timeFrame: 2 Weeks after PDT #1
measure: Edema at Visit 4
timeFrame: 8 Weeks after PDT #1
measure: Edema at Visit 5
timeFrame: 12 Weeks after PDT #1
measure: Stinging/Burning at Baseline
timeFrame: Baseline
measure: Stinging/Burning During Light Treatment
timeFrame: During PDT #1
measure: Stinging/Burning Post Light Treatment
timeFrame: 5 minutes after PDT #1
measure: Stinging/Burning at Visit 3
timeFrame: 2 Weeks after PDT #1
measure: Stinging/Burning at Visit 4
timeFrame: 8 Weeks after PDT #1
measure: Stinging/Burning at Visit 5
timeFrame: 12 Weeks after PDT #1
measure: Scaling and Dryness at Baseline
timeFrame: Baseline
measure: Scaling and Dryness at Visit 3
timeFrame: 2 Weeks Post PDT #1
measure: Scaling and Dryness at Visit 4
timeFrame: 8 Weeks Post PDT #1
measure: Scaling and Dryness at Visit 5
timeFrame: 12 Weeks Post PDT #1
measure: OOZING/VESICULATION/CRUSTING at Baseline
timeFrame: Baseline
measure: OOZING/VESICULATION/CRUSTING at Visit 3
timeFrame: Week 2 after PDT #1
measure: OOZING/VESICULATION/CRUSTING at Visit 4
timeFrame: 8 Weeks after PDT #1
measure: OOZING/VESICULATION/CRUSTING at Visit 5
timeFrame: 12 Weeks after PDT #1
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Orange Park
country: United States
facility: Park Avenue Dermatology, PA
state: Florida
city: Austin
country: United States
facility: DermResearch, Inc
state: Texas
Study officials:
affiliation: DUSA Pharmaceuticals, Inc.
name: Stuart Marcus, MD, PhD
role: STUDY_DIRECTOR
References: