Clinical trial NCT01475955: Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (AK)
Official title: A Phase II Study of Photodynamic Therapy With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light Using Spot and Broad Area Application and Incubation Times of 1, 2 and 3 Hours for the Treatment of Multiple Actinic Keratoses on the Face or Scalp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actinic Keratosis
Lead sponsor: DUSA Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-22
Enrollment: 235
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 Photodynamic Therapy (PDT) is safe and effective in the treatment of actinic keratosis when applied to broad areas on the face and scalp for 1, 2 and 3 hours.


Eligibility criteria: Inclusion Criteria:

* 6-20 Grade 1/2 AKs on the face or scalp
* a history of AK therapy within the treatment area at least twice in the two years prior to study entry

Exclusion Criteria:

* Pregnancy
* Grade 3 AKs or atypical AKs (e.g., AK \> 1 cm2 in size) within the Treatment Area
* lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
* plans to be exposed to artificial tanning devices or excessive sunlight during the trial
* Subject is immunosuppressed
* unsuccessful outcome from previous ALA-PDT therapy
* history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
* skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
* skin pathology or condition that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
* any condition which would make it unsafe for the subject to participate in this research study
* 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)
* Subject has;

  * an active herpes simplex infection OR
  * a history of 2 or more outbreaks within the past 12 months, in the Treatment Area
* 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: Complete Clearance Rate
timeFrame: Week 12
Secondary outcomes:
measure: Complete Clearance Rate
timeFrame: Week 4
measure: Complete Clearance Rate
timeFrame: Week 8
measure: Complete Clearance Rate
timeFrame: Week 24
measure: Partial Clearance Rate
timeFrame: Baseline, Week 4
measure: Partial Clearance Rate
timeFrame: Baseline, Week 8
measure: Partial Clearance Rate
timeFrame: Baseline, Week 12
measure: Partial Clearance Rate
timeFrame: Baseline Week 24
measure: AK Clearance Rate
timeFrame: Baseline, Week 4
measure: AK Clearance Rate
timeFrame: Baseline, Week 8
measure: AK Clearance Rate
timeFrame: Baseline, Week 12
measure: AK Clearance Rate
timeFrame: Baseline, Week 24
measure: Subject Satisfaction Score
timeFrame: Week 24
measure: Hyperpigmentation at Baseline
timeFrame: Baseline
measure: Hyperpigmentation at Visit 2
timeFrame: 24-48 Hours after PDT #1
measure: Hyperpigmentation at Visit 3
timeFrame: Week 2
measure: Hyperpigmentation at Visit 4
timeFrame: Week 4
measure: Hyperpigmentation at Visit 5
timeFrame: Week 8
measure: Hyperpigmentation at Visit 6
timeFrame: Week 12
measure: Hyperpigmentation at Visit 7
timeFrame: Week 24
measure: Hypopigmentation at Baseline
timeFrame: Baseline
measure: Hypopigmentation at Visit 2
timeFrame: 24-48 Hours after PDT #1
measure: Hypopigmentation at Visit 3
timeFrame: Week 2
measure: Hypopigmentation at Visit 4
timeFrame: Week 4
measure: Hypopigmentation at Visit 5
timeFrame: Week 8
measure: Hypopigmentation at Visit 6
timeFrame: Week 12
measure: Hypopigmentation at Visit 7
timeFrame: Week 24
measure: Erythema at Baseline
timeFrame: Baseline
measure: Erythema Post-Light Treatment
timeFrame: 5 minutes after PDT #1
measure: Erythema at Visit 2
timeFrame: 24-48 hours after PDT #1
measure: Erythema at Visit 3
timeFrame: Week 2
measure: Erythema at Visit 4
timeFrame: Week 4
measure: Erythema at Visit 5 (Pre-drug)
timeFrame: Week 8 pre-drug
measure: Erythema at Visit 5 (Post-light)
timeFrame: Week 8 5 minutes post light treatment
measure: Erythema at Visit 6
timeFrame: Week 12
measure: Erythema at Visit 7
timeFrame: Week 24
measure: Edema at Baseline
timeFrame: Baseline
measure: Edema Post-Light Treatment
timeFrame: 5 minutes after PDT #1
measure: Edema at Visit 2
timeFrame: 24-48 hours post PDT#1
measure: Edema at Visit 3
timeFrame: Week 2
measure: Edema at Visit 4
timeFrame: Week 4
measure: Edema at Visit 5 (Pre-drug)
timeFrame: Week 8 pre-drug
measure: Edema Post PDT #2
timeFrame: 5 minutes post PDT #2
measure: Edema at Week 12
timeFrame: Week 12
measure: Edema at Week 24
timeFrame: Week 24
measure: Stinging/Burning at Baseline
timeFrame: Baseline
measure: Stinging/Burning During Light Treatment
timeFrame: During PDT #1 (most intense sensation)
measure: Stinging/Burning Post Light-Treatment
timeFrame: 5 minutes post PDT #1
measure: Stinging/Burning at Visit 2
timeFrame: 24-48 hours post PDT #1
measure: Stinging/Burning at Visit 3
timeFrame: Week 2
measure: Stinging/Burning at Visit 4
timeFrame: Week 4
measure: Stinging/Burning at Visit 5 (Pre-drug)
timeFrame: Week 8 prior to drug
measure: Stinging/Burning at Visit 5 During PDT#2
timeFrame: during PDT #2
measure: Stinging/Burning at Visit 5 Post PDT#2
timeFrame: 5 minutes post PDT #2
measure: Stinging/Burning at Visit 6
timeFrame: Week 12
measure: Stinging/Burning at Visit 7
timeFrame: Week 24
measure: Scaling and Dryness at Baseline
timeFrame: Baseline
measure: Scaling and Dryness at Visit 2
timeFrame: 24-48 hours after PDT #1
measure: Scaling and Dryness at Visit 3
timeFrame: Week 2
measure: Scaling and Dryness at Visit 4
timeFrame: Week 4
measure: Scaling and Dryness at Visit 5
timeFrame: Week 8
measure: Scaling and Dryness at Visit 6
timeFrame: Week 12
measure: Scaling and Dryness at Visit 7
timeFrame: Week 24
measure: Oozing/Vesiculation/Crusting at Baseline
timeFrame: Baseline
measure: Oozing/Vesiculation/Crusting at Visit 2
timeFrame: 24-48 hours after PDT #1
measure: Oozing/Vesiculation/Crusting at Visit 3
timeFrame: Week 2
measure: Oozing/Vesiculation/Crusting at Visit 4
timeFrame: Week 4
measure: Oozing/Vesiculation/Crusting at Visit 5
timeFrame: Week 8
measure: Oozing/Vesiculation/Crusting at Visit 6
timeFrame: Week 12
measure: Oozing/Vesiculation/Crusting at Visit 7
timeFrame: Week 24
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Dermatology Perlman Ambulatory Clinic
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Boise
country: United States
facility: Northwest Clinical Trials, Inc.
state: Idaho
city: Arlington Heights
country: United States
facility: Altman Dermatology Associates
state: Illinois
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC
state: Indiana
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Cincinnati
country: United States
facility: Dermatology Research Center of Cincinnati
state: Ohio
city: Portland
country: United States
facility: Oregon Medical Research Center, PC
state: Oregon
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, P.A.,The Center for Skin Research
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research Inc
state: Virginia
Study officials:
affiliation: DUSA Pharmaceuticals, Inc.
name: Stuart Marcus, MD, PhD
role: STUDY_DIRECTOR
References: