Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities

Phase 3

Completed

• Conditions: Actinic Keratosis
• Interventions: Drug: Aminolevulinic Acid (ALA); Drug: Topical Solution Vehicle; Device: Blue Light Photodynamic Therapy Illuminator (BLU-U)

• Registration Number: NCT02137785
• Lead Sponsor: 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 keratoses on the upper arms and hands

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-07
• Study First Submitted QC: 2014-05-13
• Study First Posted: 2014-05-14
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Results First Submitted: 2015-07-22
• Status Verified: 2015-08
• Results First Submitted QC: 2015-08-17
• Last Update Submitted: 2015-08-17
• Results First Posted: 2015-09-16
• Last Update Posted: 2015-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 269

Inclusion Criteria

• Four to fifteen Grade 1/2 actinic keratosis lesions (AKs) on one upper extremity

Exclusion Criteria

• Pregnancy

• grade 3 and/or atypical >1cm AKs within Treatment Area

• 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

• unsuccessful outcome from previous ALA-PDT therapy

• 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)

• 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 of initiation of treatment.
  • Cryotherapy within 2 weeks of initiation of treatment
  • Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks of initiation of treatment.
  • Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment.

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Blue Light Photodynamic Therapy Illuminator (BLU-U)	-
ALA	Aminolevulinic Acid (ALA)	-
ALA	Blue Light Photodynamic Therapy Illuminator (BLU-U)	-
Vehicle	Topical Solution Vehicle	-

Primary Outcome Measures

Name	Time	Method
Complete Clearance Rate	Week 12	proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area

Secondary Outcome Measures

Name	Time	Method
Complete Clearance Rate	Week 8	proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
AK Clearance Rate	Baseline and Week 8	{1 - \[(number of AK lesions at follow-up)/(number of AK lesions at Baseline)\]} x 100
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)

Trial Locations

Locations (13)

Oregon Dermatology and Research Center; 🇺🇸 Portland, Oregon, United States

Virginia Clinical Research, Inc.; 🇺🇸 Norfolk, Virginia, United States

Center for Clinical and Cosmetic Research; 🇺🇸 Aventura, Florida, United States

MOORE Clinical Research, Inc; 🇺🇸 Brandon, Florida, United States

Altman Dermatology Associates; 🇺🇸 Arlington Heights, Illinois, United States

The Indiana Clinical Trials Center, PC; 🇺🇸 Plainfield, Indiana, United States

Center For Dermatology Clinical Research, Inc.; 🇺🇸 Fremont, California, United States

Shideler Clinical Research Center; 🇺🇸 Carmel, Indiana, United States

Minnesota Clinical Study Center; 🇺🇸 Fridley, Minnesota, United States

Spencer Clinical Services; 🇺🇸 St. Petersburg, Florida, United States

Suzanne Bruce and Associates, P.A.,The Center for Skin Research; 🇺🇸 Houston, Texas, United States

J&S Studies, Inc; 🇺🇸 College Station, Texas, United States

UCSD Dermatology; 🇺🇸 San Diego, California, United States