Clinical trial NCT02137785: Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities
Official title: A Phase 3 Study of Photodynamic Therapy With Levulan Kerastick Topical Solution + Blue Light Versus Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
Lead sponsor: DUSA Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-14
Enrollment: 269
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 keratoses on the upper arms and hands


Eligibility criteria: Inclusion Criteria:

* Four to fifteen Grade 1/2 actinic keratosis lesions (AKs) on one upper extremity

Exclusion Criteria:

* Pregnancy
* grade 3 and/or atypical \>1cm AKs within Treatment Area
* 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 extremity 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, within 4 weeks of initiation of treatment.
  * Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment.
* use of systemic retinoid therapy within 6 months of initiation of treatment.

Primary outcomes:
measure: Complete Clearance Rate
timeFrame: Week 12
Secondary outcomes:
measure: AK Clearance Rate
timeFrame: Baseline and Week 12
measure: AK Clearance Rate
timeFrame: Baseline and Week 8
measure: Complete Clearance Rate
timeFrame: Week 8
measure: Subject Satisfaction Score
timeFrame: Week 12
Other outcomes:
measure: Hyperpigmentation
timeFrame: Baseline
measure: Hyperpigmentation
timeFrame: 24-48 hours after PDT #1
measure: Hyperpigmentation
timeFrame: 2 Weeks after PDT #1
measure: Hyperpigmentation
timeFrame: 4 Weeks after PDT #1
measure: Hyperpigmentation
timeFrame: 8 Weeks after PDT #1
measure: Hyperpigmentation
timeFrame: 12 Weeks after PDT #1
measure: Hypopigmentation
timeFrame: Baseline
measure: Hypopigmentation
timeFrame: 24-48 hours after PDT #1
measure: Hypopigmentation
timeFrame: 2 Weeks after PDT #1
measure: Hypopigmentation
timeFrame: 4 Weeks after PDT #1
measure: Hypopigmentation
timeFrame: 8 Weeks after PDT #1
measure: Hypopigmentation
timeFrame: 12 Weeks after PDT #1
measure: Erythema
timeFrame: Baseline
measure: Erythema
timeFrame: 5 minutes after PDT #1
measure: Erythema
timeFrame: 24-48 hours after PDT #1
measure: Erythema
timeFrame: 2 Weeks after PDT #1
measure: Erythema
timeFrame: 4 Weeks after PDT #1
measure: Erythema
timeFrame: 8 Weeks after PDT #1
measure: Erythema
timeFrame: 12 Weeks after PDT #1
measure: Edema
timeFrame: Baseline
measure: Edema
timeFrame: 5 minutes after PDT #1
measure: Edema
timeFrame: 24-48 hours after PDT #1
measure: Edema
timeFrame: 2 weeks after PDT #1
measure: Edema
timeFrame: 4 Weeks after PDT #1
measure: Edema
timeFrame: 8 Weeks after PDT #1
measure: Edema
timeFrame: 12 Weeks after PDT #1
measure: Stinging/Burning
timeFrame: Baseline
measure: Stinging/Burning
timeFrame: During PDT #1
measure: Stinging/Burning
timeFrame: 5 minutes after PDT #1
measure: Stinging/Burning
timeFrame: 24-48 Hours after PDT #1
measure: Stinging/Burning
timeFrame: 2 Weeks after PDT #1
measure: Stinging/Burning
timeFrame: 4 Weeks after PDT #1
measure: Stinging/Burning
timeFrame: 8 Weeks after PDT #1
measure: Stinging/Burning
timeFrame: 12 Weeks after PDT #1
measure: Scaling & Dryness
timeFrame: Baseline
measure: Scaling & Dryness
timeFrame: 24-48 hours after PDT #1
measure: Scaling & Dryness
timeFrame: 2 Weeks after PDT #1
measure: Scaling & Dryness
timeFrame: 4 Weeks after PDT #1
measure: Scaling & Dryness
timeFrame: 8 Weeks after PDT #1
measure: Scaling & Dryness
timeFrame: 12 Weeks after PDT #1
measure: Oozing/Vesiculation/Crusting
timeFrame: Baseline
measure: Oozing/Vesiculation/Crusting
timeFrame: 24-48 hours after PDT #1
measure: Oozing/Vesiculation/Crusting
timeFrame: 2 Weeks after PDT #1
measure: Oozing/Vesiculation/Crusting
timeFrame: 4 Weeks after PDT #1
measure: Oozing/Vesiculation/Crusting
timeFrame: 8 Weeks after PDT #1
measure: Oozing/Vesiculation/Crusting
timeFrame: 12 Weeks after PDT #1
Locations:
city: Fremont
country: United States
facility: Center For Dermatology Clinical Research, Inc.
state: California
city: San Diego
country: United States
facility: UCSD Dermatology
state: California
city: Aventura
country: United States
facility: Center for Clinical and Cosmetic Research
state: Florida
city: Brandon
country: United States
facility: MOORE Clinical Research, Inc
state: Florida
city: St. Petersburg
country: United States
facility: Spencer Clinical Services
state: Florida
city: Arlington Heights
country: United States
facility: Altman Dermatology Associates
state: Illinois
city: Carmel
country: United States
facility: Shideler Clinical Research Center
state: Indiana
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: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: College Station
country: United States
facility: J&S Studies, 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: