Microneedle Lesion Preparation Prior to Aminolevulinic Acid Photodynamic Therapy (ALA-PDT) for AK on Face

Phase 2

Completed

Conditions: Actinic Keratosis

Interventions: Drug: ALA
Drug: Topical Solution Vehicle
Device: IBL 10 mW
Device: IBL 20 mW
Procedure: Microneedle lesion preparation

Registration Number: NCT02632110

Lead Sponsor: DUSA Pharmaceuticals, Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 137

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALA 60 min 20 mW	ALA	ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
MN + ALA 60 min 10 mW	ALA	Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
MN + ALA 60 min 10 mW	IBL 10 mW	Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
MN + ALA 60 min 10 mW	Microneedle lesion preparation	Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
MN + VEH	IBL 10 mW	Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
MN + VEH	Microneedle lesion preparation	Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
ALA 25 min 10 Milliwatts (mW)	IBL 10 mW	ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
ALA 60 min 20 mW	IBL 20 mW	ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
MN + ALA 60 min 20 mW	ALA	Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
MN + ALA 60 min 20 mW	Microneedle lesion preparation	Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
MN + ALA 25 min 10 mW	ALA	Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
MN + ALA 25 min 10 mW	IBL 10 mW	Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
MN + ALA 60 min 20 mW	IBL 20 mW	Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
VEH	Topical Solution Vehicle	Vehicle (VEH) PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
VEH	IBL 10 mW	Vehicle (VEH) PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
MN + ALA 25 min 10 mW	Microneedle lesion preparation	Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
ALA 25 min 20 mW	ALA	ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
ALA 25 min 20 mW	IBL 20 mW	ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
MN + ALA 25 min 20 mW	Microneedle lesion preparation	Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
MN + ALA 25 min 20 mW	IBL 20 mW	Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
ALA 60 min 10 mW	IBL 10 mW	ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
MN + VEH	Topical Solution Vehicle	Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
ALA 60 min 10 mW	ALA	ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
ALA 25 min 10 Milliwatts (mW)	ALA	ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
MN + ALA 25 min 20 mW	ALA	Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.

Primary Outcome Measures

Name	Time	Method
Complete Clearance Rate	Week 12	Number of AK Fields with 0 lesions

Secondary Outcome Measures

Name	Time	Method
Complete Clearance Rate	Week 8	Number of AK Fields with 0 Lesions
Percent Change	Baseline and Week 12	Percent change in the total AK number as compared with Baseline
Subject Satisfaction Score	Week 12	Subject satisfaction score 1. = Excellent (very satisfied) 2. = Good (moderately satisfied) 3. = Fair (slightly satisfied) 4. = Poor (not satisfied at all)
Baseline AKCR	Baseline and Week 12	AK clearance rate for only those lesions present at Baseline

Trial Locations

Locations (8): Minnesota Clinical Study Center
🇺🇸
Fridley, Minnesota, United States
Virginia Clinical Research, Inc.
🇺🇸
Norfolk, Virginia, United States
UCSD Dermatology
🇺🇸
San Diego, California, United States
MOORE Clinical Research, Inc
🇺🇸
Brandon, Florida, United States
Therapeutics Clinical Research
🇺🇸
San Diego, California, United States
Shideler Clinical Research Center
🇺🇸
Carmel, Indiana, United States
The Indiana Clinical Trials Center, PC
🇺🇸
Plainfield, Indiana, United States
Altman Dermatology Associates
🇺🇸
Arlington Heights, Illinois, United States