Phase 3 Study of Levulan With New Blue Light for AK on the Face or Scalp

NCT03024060 | Withdrawn Phase 3 FDA Drug FDA Device

• 1 other identifier: CP0114
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to prove the safety and efficacy of Levulan Kerastick (aminolevulinic acid HCl) for Topical Solution 20% followed by 10 J/cm2 of blue light delivered at 10 mW/cm2 or 20 mW/cm2 in the treatment of multiple actinic keratosis on the face or balding scalp (the Treatment Area), utilizing a 14-18 hour incubation period.

Conditions

Actinic Keratosis

Keywords

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• Complete Clearance Rate

  proportion of subjects in each treatment group with 100% clearance of Baseline target lesions

  Week 12

Secondary Outcomes (5)

• Baseline AK Clearance Rate

  Baseline and Week 12

• Baseline AK Clearance Rate

  Baseline and Week 8

• Complete Clearance Rate

  Week 8

• Baseline AK Clearance Rate

  Baseline and Week 4

• Complete Clearance Rate

  Week 4

Other Outcomes (62)

• Hyperpigmentation

  Baseline

• Hyperpigmentation

  14-18 hours after Baseline - prior to light treatment

• Hyperpigmentation

  24 hours after PDT #1

Study Arms (3)

ALA 20 mW

EXPERIMENTAL

ALA + IBL 10J at 20 mW (8min 20 sec)

Drug: ALA; Device: IBL 20 mW

ALA 10 mW

EXPERIMENTAL

ALA + IBL 10J at 10 mW (16 min 40 sec)

Drug: ALA; Device: IBL 10 mW

Vehicle

PLACEBO COMPARATOR

Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving light treatment delivered at 20 mW/cm2 OR 10 mW/cm2. Subjects receiving VEH will be considered a single treatment group

Drug: Vehicle; Device: IBL 20 mW; Device: IBL 10 mW

Interventions

ALA DRUG

20% ALA applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light

Also known as: Levulan Kerastick, Aminolevulinic Acid

ALA 10 mW; ALA 20 mW

Vehicle DRUG

Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light

Also known as: Topical Solution Vehicle

Vehicle

IBL 20 mW DEVICE

10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds

Also known as: Investigational Blue Light

ALA 20 mW; Vehicle

IBL 10 mW DEVICE

10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds

Also known as: Investigational Blue Light

ALA 10 mW; Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Four to fifteen Grade 1/2 actinic keratosis lesions (AKs) on the face OR balding scalp

You may not qualify if:

• Pregnancy
• grade 3 and/or atypical \>1cm AKs within Treatment Area and/or more than 15 AKs of any Grade within the 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)
• has active herpes simplex infection in the Treatment Area OR a history of 2 or more outbreaks within past 12 months, in the Treatment Area
• 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.
• Curettage or Cryotherapy within 2 weeks of initiation of treatment
• Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks of initiation of treatment.

Sponsors & Collaborators

• DUSA Pharmaceuticals, Inc.: lead

Study Sites (7)

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Altman Dermatology Associates

Arlington Heights, Illinois, 60005, United States

Location

Shideler Clinical Research Center

Carmel, Indiana, 46032, United States

Location

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, 46168, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Aminolevulinic Acid; Solutions

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Pharmaceutical Preparations

Study Officials

• Stuart Marcus, MD, PhD

  DUSA Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 18, 2017
• Study Start: March 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: January 1, 2018
• Last Updated: November 7, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)