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

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

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.

Study Overview

• Status: Completed
• Conditions: Actinic Keratosis
• Intervention / Treatment: Drug: ALA; Device: IBL 10 mW; Procedure: Microneedle lesion preparation; Device: IBL 20 mW; Drug: Topical Solution Vehicle

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92122
      • UCSD Dermatology
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
  • Florida
    • Brandon, Florida, United States, 33609
      • MOORE Clinical Research, Inc
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Altman Dermatology Associates
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Shideler Clinical Research Center
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center, PC
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Minnesota Clinical Study Center
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ALA 25 min 10 Milliwatts (mW); ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.	Drug: ALA; 20% ALA applied to face prior to light treatment; Other Names: Levulan Kerastick; Aminolevulinic acid; Device: IBL 10 mW; 10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds; Other Names: Investigational Blue Light (IBL)
EXPERIMENTAL: MN + ALA 25 min 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.	Drug: ALA; 20% ALA applied to face prior to light treatment; Other Names: Levulan Kerastick; Aminolevulinic acid; Device: IBL 10 mW; 10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds; Other Names: Investigational Blue Light (IBL); Procedure: Microneedle lesion preparation; Microneedling of all visible/palpable AK lesions prior to solution application.
EXPERIMENTAL: ALA 25 min 20 mW; ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.	Drug: ALA; 20% ALA applied to face prior to light treatment; Other Names: Levulan Kerastick; Aminolevulinic acid; Device: IBL 20 mW; 10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds; Other Names: Investigational Blue Light
EXPERIMENTAL: MN + ALA 25 min 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.	Drug: ALA; 20% ALA applied to face prior to light treatment; Other Names: Levulan Kerastick; Aminolevulinic acid; Procedure: Microneedle lesion preparation; Microneedling of all visible/palpable AK lesions prior to solution application.; Device: IBL 20 mW; 10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds; Other Names: Investigational Blue Light
EXPERIMENTAL: ALA 60 min 10 mW; ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.	Drug: ALA; 20% ALA applied to face prior to light treatment; Other Names: Levulan Kerastick; Aminolevulinic acid; Device: IBL 10 mW; 10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds; Other Names: Investigational Blue Light (IBL)
EXPERIMENTAL: MN + ALA 60 min 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.	Drug: ALA; 20% ALA applied to face prior to light treatment; Other Names: Levulan Kerastick; Aminolevulinic acid; Device: IBL 10 mW; 10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds; Other Names: Investigational Blue Light (IBL); Procedure: Microneedle lesion preparation; Microneedling of all visible/palpable AK lesions prior to solution application.
EXPERIMENTAL: ALA 60 min 20 mW; ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.	Drug: ALA; 20% ALA applied to face prior to light treatment; Other Names: Levulan Kerastick; Aminolevulinic acid; Device: IBL 20 mW; 10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds; Other Names: Investigational Blue Light
EXPERIMENTAL: MN + ALA 60 min 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.	Drug: ALA; 20% ALA applied to face prior to light treatment; Other Names: Levulan Kerastick; Aminolevulinic acid; Procedure: Microneedle lesion preparation; Microneedling of all visible/palpable AK lesions prior to solution application.; Device: IBL 20 mW; 10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds; Other Names: Investigational Blue Light
PLACEBO_COMPARATOR: VEH; Vehicle (VEH) PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.	Device: IBL 10 mW; 10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds; Other Names: Investigational Blue Light (IBL); Drug: Topical Solution Vehicle; Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment
PLACEBO_COMPARATOR: MN + VEH; Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.	Device: IBL 10 mW; 10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds; Other Names: Investigational Blue Light (IBL); Procedure: Microneedle lesion preparation; Microneedling of all visible/palpable AK lesions prior to solution application.; Drug: Topical Solution Vehicle; Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Clearance Rate	Number of AK Fields with 0 lesions	Week 12

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hyperpigmentation	HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas	Baseline
Hyperpigmentation	HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas	12 Weeks after PDT #1
Erythema	Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema	Baseline
Erythema	Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema	5 minutes after PDT #1
Erythema	Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema	24-48 hours after PDT #1
Erythema	Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema	12 Weeks after PDT #1
Edema	EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area	Baseline
Edema	EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area	5 minutes after PDT #1
Edema	EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area	24-48 hours after PDT #1
Edema	EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area	12 Weeks after PDT #1
Stinging/Burning	STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable	Baseline
Stinging/Burning	Immediately after PDT, the most intensive, acute perception of Stinging/Burning DURING treatment will be recorded. STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable	During PDT #1
Stinging/Burning	STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable	5 minutes after PDT #1
Stinging/Burning	STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable	12 Weeks after PDT #1
Scaling & Dryness	SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling	Baseline
Scaling & Dryness	SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling	24-48 hours after PDT #1
Scaling & Dryness	SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling	12 Weeks after PDT #1
Oozing/Vesiculation/Crusting	OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above	Baseline
Oozing/Vesiculation/Crusting	OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above	24-48 hours after PDT #1
Oozing/Vesiculation/Crusting	OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above	12 Weeks after PDT #1
Hyperpigmentation	HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas	24-48 hours after PDT #1
Hyperpigmentation	HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas	2 Weeks after PDT #1
Hyperpigmentation	HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas	8 Weeks after PDT #1
Hypopigmentation	HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas	Baseline
Hypopigmentation	HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas	24-48 hours after PDT #1
Hypopigmentation	HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas	2 Weeks after PDT #1
Hypopigmentation	HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas	8 Weeks after PDT #1
Hypopigmentation	HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas	12 Weeks after PDT #1
Erythema	Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema	2 Weeks after PDT #1
Erythema	Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema	8 Weeks after PDT #1
Edema	EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area	2 weeks after PDT #1
Edema	EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area	8 Weeks after PDT #1
Stinging/Burning	STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable	24-48 Hours after PDT #1
Stinging/Burning	STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable	2 Weeks after PDT #1
Stinging/Burning	STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable	8 Weeks after PDT #1
Scaling & Dryness	SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling	2 Weeks after PDT #1
Scaling & Dryness	SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling	8 Weeks after PDT #1
Oozing/Vesiculation/Crusting	OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above	2 Weeks after PDT #1
Oozing/Vesiculation/Crusting	OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above	8 Weeks after PDT #1

Collaborators and Investigators

• Sponsor: DUSA Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (ACTUAL): September 12, 2016
• Study Completion (ACTUAL): September 12, 2016

Study Registration Dates

• First Submitted: December 14, 2015
• First Submitted That Met QC Criteria: December 14, 2015
• First Posted (ESTIMATE): December 16, 2015

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2018
• Last Update Submitted That Met QC Criteria: December 18, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Actinic Keratosis
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Photosensitizing Agents; Dermatologic Agents; Aminolevulinic Acid
• Other Study ID Numbers: CP0112