Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (AK)

A Phase II Study of Photodynamic Therapy With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light Using Spot and Broad Area Application and Incubation Times of 1, 2 and 3 Hours for the Treatment of Multiple Actinic Keratoses on the Face or Scalp

Sponsors

Lead Sponsor: DUSA Pharmaceuticals, Inc.

Source DUSA Pharmaceuticals, Inc.
Brief Summary

The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and effective in the treatment of actinic keratosis when applied to broad areas on the face and scalp for 1, 2 and 3 hours.

Overall Status Completed
Start Date December 2011
Completion Date November 2012
Primary Completion Date November 2012
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Complete Clearance Rate Week 12
Secondary Outcome
Measure Time Frame
Complete Clearance Rate Week 4
Complete Clearance Rate Week 8
Complete Clearance Rate Week 24
Partial Clearance Rate Baseline, Week 4
Partial Clearance Rate Baseline, Week 8
Partial Clearance Rate Baseline, Week 12
Partial Clearance Rate Baseline Week 24
AK Clearance Rate Baseline, Week 4
AK Clearance Rate Baseline, Week 8
AK Clearance Rate Baseline, Week 12
AK Clearance Rate Baseline, Week 24
Subject Satisfaction Score Week 24
Hyperpigmentation at Baseline Baseline
Hyperpigmentation at Visit 2 24-48 Hours after PDT #1
Hyperpigmentation at Visit 3 Week 2
Hyperpigmentation at Visit 4 Week 4
Hyperpigmentation at Visit 5 Week 8
Hyperpigmentation at Visit 6 Week 12
Hyperpigmentation at Visit 7 Week 24
Hypopigmentation at Baseline Baseline
Hypopigmentation at Visit 2 24-48 Hours after PDT #1
Hypopigmentation at Visit 3 Week 2
Hypopigmentation at Visit 4 Week 4
Hypopigmentation at Visit 5 Week 8
Hypopigmentation at Visit 6 Week 12
Hypopigmentation at Visit 7 Week 24
Erythema at Baseline Baseline
Erythema Post-Light Treatment 5 minutes after PDT #1
Erythema at Visit 2 24-48 hours after PDT #1
Erythema at Visit 3 Week 2
Erythema at Visit 4 Week 4
Erythema at Visit 5 (Pre-drug) Week 8 pre-drug
Erythema at Visit 5 (Post-light) Week 8 5 minutes post light treatment
Erythema at Visit 6 Week 12
Erythema at Visit 7 Week 24
Edema at Baseline Baseline
Edema Post-Light Treatment 5 minutes after PDT #1
Edema at Visit 2 24-48 hours post PDT#1
Edema at Visit 3 Week 2
Edema at Visit 4 Week 4
Edema at Visit 5 (Pre-drug) Week 8 pre-drug
Edema Post PDT #2 5 minutes post PDT #2
Edema at Week 12 Week 12
Edema at Week 24 Week 24
Stinging/Burning at Baseline Baseline
Stinging/Burning During Light Treatment During PDT #1 (most intense sensation)
Stinging/Burning Post Light-Treatment 5 minutes post PDT #1
Stinging/Burning at Visit 2 24-48 hours post PDT #1
Stinging/Burning at Visit 3 Week 2
Stinging/Burning at Visit 4 Week 4
Stinging/Burning at Visit 5 (Pre-drug) Week 8 prior to drug
Stinging/Burning at Visit 5 During PDT#2 during PDT #2
Stinging/Burning at Visit 5 Post PDT#2 5 minutes post PDT #2
Stinging/Burning at Visit 6 Week 12
Stinging/Burning at Visit 7 Week 24
Scaling and Dryness at Baseline Baseline
Scaling and Dryness at Visit 2 24-48 hours after PDT #1
Scaling and Dryness at Visit 3 Week 2
Scaling and Dryness at Visit 4 Week 4
Scaling and Dryness at Visit 5 Week 8
Scaling and Dryness at Visit 6 Week 12
Scaling and Dryness at Visit 7 Week 24
Oozing/Vesiculation/Crusting at Baseline Baseline
Oozing/Vesiculation/Crusting at Visit 2 24-48 hours after PDT #1
Oozing/Vesiculation/Crusting at Visit 3 Week 2
Oozing/Vesiculation/Crusting at Visit 4 Week 4
Oozing/Vesiculation/Crusting at Visit 5 Week 8
Oozing/Vesiculation/Crusting at Visit 6 Week 12
Oozing/Vesiculation/Crusting at Visit 7 Week 24
Enrollment 235
Condition
Intervention

Intervention Type: Drug

Intervention Name: Broad Area ALA 1-hour incubation

Description: 20% ALA, broad area, 1 hour incubation

Arm Group Label: Broad Area ALA 1-hour incubation

Other Name: Levulan

Intervention Type: Drug

Intervention Name: Broad Area ALA 2 hour incubation

Description: 20% ALA broad area 2-hour incubation

Arm Group Label: Broad Area ALA 2-hour incubation

Other Name: Levulan

Intervention Type: Drug

Intervention Name: broad area ALA 3-hour incubation

Description: 20% ALA broad area 3 hour incubation

Arm Group Label: Broad Area ALA 3-hour incubation

Other Name: Levulan

Intervention Type: Drug

Intervention Name: Spot ALA 2 hour incubation

Description: 20% ALA spot 2 hour incubation

Arm Group Label: Spot ALA 2-hour incubation

Other Name: Levulan

Intervention Type: Drug

Intervention Name: Vehicle PDT

Description: Levulan Kerastick containing vehicle ingredients only.VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.

Arm Group Label: Vehicle PDT

Intervention Type: Device

Intervention Name: Blue Light Treatment

Description: 10 J/cm2 blue light delivered at 10 mW/cm2

Other Name: BLU-U

Eligibility

Criteria:

Inclusion Criteria:

- 6-20 Grade 1/2 AKs on the face or scalp

- a history of AK therapy within the treatment area at least twice in the two years prior to study entry

Exclusion Criteria:

- Pregnancy

- Grade 3 AKs or atypical AKs (e.g., AK > 1 cm2 in size) within the Treatment Area

- lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area

- plans to be exposed to artificial tanning devices or excessive sunlight during the trial

- Subject is immunosuppressed

- unsuccessful outcome from previous ALA-PDT therapy

- history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis

- skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy

- skin pathology or condition that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy

- any condition which would make it unsafe for the subject to participate in this research study

- 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)

- Subject has;

- an active herpes simplex infection OR

- a history of 2 or more outbreaks within the past 12 months, in the Treatment Area

- use of the following topical preparations on the extremities 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, retinol, within 4 weeks of initiation of treatment.

- Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment.

- Two or more ALA PDT treatments in the past 6 months

- use of systemic retinoid therapy within 6 months of initiation of treatment.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Stuart Marcus, MD, PhD Study Director DUSA Pharmaceuticals, Inc.
Location
Facility:
UCSD Dermatology Perlman Ambulatory Clinic | La Jolla, California, 92037, United States
Dermatology Research Associates | Los Angeles, California, 90045, United States
Therapeutics Clinical Research | San Diego, California, 92123, United States
Northwest Clinical Trials, Inc. | Boise, Idaho, 83704, United States
Altman Dermatology Associates | Arlington Heights, Illinois, 60005, United States
The Indiana Clinical Trials Center, PC | Plainfield, Indiana, 46168, United States
Minnesota Clinical Study Center | Fridley, Minnesota, 55432, United States
Dermatology Research Center of Cincinnati | Cincinnati, Ohio, 45220, United States
Oregon Medical Research Center, PC | Portland, Oregon, 97223, United States
Tennessee Clinical Research Center | Nashville, Tennessee, 37215, United States
DermResearch, Inc. | Austin, Texas, 78759, United States
Suzanne Bruce and Associates, P.A.,The Center for Skin Research | Houston, Texas, 77056, United States
Virginia Clinical Research Inc | Norfolk, Virginia, 23507, United States
Location Countries

United States

Verification Date

September 2016

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 5
Arm Group

Label: Broad Area ALA 1-hour incubation

Type: Experimental

Description: Broad Area ALA 1-hour incubation

Label: Broad Area ALA 2-hour incubation

Type: Experimental

Description: Broad Area ALA 2-hour incubation

Label: Broad Area ALA 3-hour incubation

Type: Experimental

Description: Broad Area ALA 3-hour incubation

Label: Spot ALA 2-hour incubation

Type: Experimental

Description: Spot ALA 2-hour incubation

Label: Vehicle PDT

Type: Placebo Comparator

Description: VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov