Overview

This trial is active, not recruiting.

Condition actinic keratosis
Treatments ala, topical solution vehicle, ibl 10 mw, microneedle lesion preparation, ibl 20 mw
Phase phase 2
Sponsor DUSA Pharmaceuticals, Inc.
Start date March 2016
End date September 2016
Trial size 137 participants
Trial identifier NCT02632110, CP0112

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
ala Levulan Kerastick
20% ALA applied to face prior to light treatment
ibl 10 mw Investigational Blue Light
10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
(Experimental)
Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
ala Levulan Kerastick
20% ALA applied to face prior to light treatment
ibl 10 mw Investigational Blue Light
10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
microneedle lesion preparation
Microneedling of all visible/palpable AK lesions prior to solution application.
(Experimental)
ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
ala Levulan Kerastick
20% ALA applied to face prior to light treatment
ibl 20 mw Investigational Blue Light
10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds
(Experimental)
Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
ala Levulan Kerastick
20% ALA applied to face prior to light treatment
microneedle lesion preparation
Microneedling of all visible/palpable AK lesions prior to solution application.
ibl 20 mw Investigational Blue Light
10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds
(Experimental)
ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
ala Levulan Kerastick
20% ALA applied to face prior to light treatment
ibl 10 mw Investigational Blue Light
10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
(Experimental)
Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
ala Levulan Kerastick
20% ALA applied to face prior to light treatment
ibl 10 mw Investigational Blue Light
10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
microneedle lesion preparation
Microneedling of all visible/palpable AK lesions prior to solution application.
(Experimental)
ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
ala Levulan Kerastick
20% ALA applied to face prior to light treatment
ibl 20 mw Investigational Blue Light
10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds
(Experimental)
Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.
ala Levulan Kerastick
20% ALA applied to face prior to light treatment
microneedle lesion preparation
Microneedling of all visible/palpable AK lesions prior to solution application.
ibl 20 mw Investigational Blue Light
10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds
(Placebo Comparator)
Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
topical solution vehicle
Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment
ibl 10 mw Investigational Blue Light
10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
(Placebo Comparator)
Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
topical solution vehicle
Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment
ibl 10 mw Investigational Blue Light
10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
microneedle lesion preparation
Microneedling of all visible/palpable AK lesions prior to solution application.

Primary Outcomes

Measure
Complete Clearance Rate
time frame: Week 12

Secondary Outcomes

Measure
Complete Clearance Rate
time frame: Week 8
Subject Satisfaction Score
time frame: Week 12
Baseline AKCR
time frame: Baseline and Week 8
Baseline AKCR
time frame: Baseline and Week 12
Percent change
time frame: Baseline and Week 8
Percent change
time frame: Baseline and Week 12

Eligibility Criteria

Male or female participants at least 18 years old.

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-FU, diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks - use of systemic retinoid therapy within 6 months

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by DUSA Pharmaceuticals, Inc..