Clinical trial NCT02632110: Microneedle Lesion Preparation Prior to Aminolevulinic Acid Photodynamic Therapy (ALA-PDT) for AK on Face
Official title: A Phase 2 Study of the Effect of Microneedle Lesion Preparation, Incubation Time and Light Power Density on Photodynamic Therapy With Levulan Kerastick (Aminolevulinic Acid HCl) for Topical Solution, 20% + Blue Light for the Field Treatment of Actinic Keratoses on the Face
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
Lead sponsor: DUSA Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-12-16
Enrollment: 137
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 the viability of microneedle lesion preparation (MN) to enhance treatment benefit when performed prior to ALA PDT to an actinic keratosis (AK) field on the face.


Eligibility criteria: Inclusion Criteria:

* Four to eight AKs on the face

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
* 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)
* has an active herpes simplex infection OR a history of 2 or more outbreaks within the past 12 months, on the face
* 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
  * Curettage or Cryotherapy within 2 weeks of initiation of treatment
  * Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks
  * Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5 fluorouracil, diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks
* use of systemic retinoid therapy within 6 months

Primary outcomes:
measure: Complete Clearance Rate
timeFrame: Week 12
Secondary outcomes:
measure: Complete Clearance Rate
timeFrame: Week 8
measure: Subject Satisfaction Score
timeFrame: Week 12
measure: Baseline AKCR
timeFrame: Baseline and Week 8
measure: Baseline AKCR
timeFrame: Baseline and Week 12
measure: Percent Change
timeFrame: Baseline and Week 8
measure: Percent Change
timeFrame: Baseline and 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: 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: 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: 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: 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: 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: 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: 8 Weeks after PDT #1
measure: Oozing/Vesiculation/Crusting
timeFrame: 12 Weeks after PDT #1
Locations:
city: San Diego
country: United States
facility: UCSD Dermatology
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Brandon
country: United States
facility: MOORE Clinical Research, Inc
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: 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: