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

NCT02632110 | Completed Phase 2 Results

• 1 other identifier: CP0112
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Actinic Keratosis

Keywords

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• Complete Clearance Rate

  Number of AK Fields with 0 lesions

  Week 12

Secondary Outcomes (6)

• Complete Clearance Rate

  Week 8

• Subject Satisfaction Score

  Week 12

• Baseline AKCR

  Baseline and Week 8

• Baseline AKCR

  Baseline and Week 12

• Percent Change

  Baseline and Week 8

Other Outcomes (39)

• Hyperpigmentation

  Baseline

• Hyperpigmentation

  24-48 hours after PDT #1

• Hyperpigmentation

  2 Weeks after PDT #1

Study Arms (10)

ALA 25 min 10 Milliwatts (mW)

EXPERIMENTAL

ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.

Drug: ALA; Device: IBL 10 mW

MN + ALA 25 min 10 mW

EXPERIMENTAL

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; Device: IBL 10 mW; Procedure: Microneedle lesion preparation

ALA 25 min 20 mW

EXPERIMENTAL

ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.

Drug: ALA; Device: IBL 20 mW

MN + ALA 25 min 20 mW

EXPERIMENTAL

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; Procedure: Microneedle lesion preparation; Device: IBL 20 mW

ALA 60 min 10 mW

EXPERIMENTAL

ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.

Drug: ALA; Device: IBL 10 mW

MN + ALA 60 min 10 mW

EXPERIMENTAL

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; Device: IBL 10 mW; Procedure: Microneedle lesion preparation

ALA 60 min 20 mW

EXPERIMENTAL

ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.

Drug: ALA; Device: IBL 20 mW

MN + ALA 60 min 20 mW

EXPERIMENTAL

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; Procedure: Microneedle lesion preparation; Device: IBL 20 mW

VEH

PLACEBO COMPARATOR

Vehicle (VEH) PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.

Drug: Topical Solution Vehicle; Device: IBL 10 mW

MN + VEH

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.

Drug: Topical Solution Vehicle; Device: IBL 10 mW; Procedure: Microneedle lesion preparation

Interventions

ALA DRUG

20% ALA applied to face prior to light treatment

Also known as: Levulan Kerastick, Aminolevulinic acid

ALA 25 min 10 Milliwatts (mW); ALA 25 min 20 mW; ALA 60 min 10 mW; ALA 60 min 20 mW; MN + ALA 25 min 10 mW; MN + ALA 25 min 20 mW; MN + ALA 60 min 10 mW; MN + ALA 60 min 20 mW

Topical Solution Vehicle DRUG

Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment

MN + VEH; VEH

IBL 10 mW DEVICE

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

Also known as: Investigational Blue Light (IBL)

ALA 25 min 10 Milliwatts (mW); ALA 60 min 10 mW; MN + ALA 25 min 10 mW; MN + ALA 60 min 10 mW; MN + VEH; VEH

Microneedle lesion preparation PROCEDURE

Microneedling of all visible/palpable AK lesions prior to solution application.

MN + ALA 25 min 10 mW; MN + ALA 25 min 20 mW; MN + ALA 60 min 10 mW; MN + ALA 60 min 20 mW; MN + VEH

IBL 20 mW DEVICE

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

Also known as: Investigational Blue Light

ALA 25 min 20 mW; ALA 60 min 20 mW; MN + ALA 25 min 20 mW; MN + ALA 60 min 20 mW

Eligibility Criteria

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

You may qualify if:

• Four to eight AKs on the face

You may not qualify if:

• 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

Sponsors & Collaborators

• DUSA Pharmaceuticals, Inc.: lead

Study Sites (8)

UCSD Dermatology

San Diego, California, 92122, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

MOORE Clinical Research, Inc

Brandon, Florida, 33609, 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

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

Results Point of Contact

• Title: Anna Houlihan
• Organization: DUSA Pharmaceuticals Inc., a Sun Pharma Co.

anna.houlihan@sunpharma.com

9147608796

Study Officials

• Stuart Marcus, MD, PhD

  DUSA Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: December 14, 2015
• First Posted: December 16, 2015
• Study Start: March 1, 2016
• Primary Completion: September 12, 2016
• Study Completion: September 12, 2016
• Last Updated: January 18, 2018
• Results First Posted: December 13, 2017

Record last verified: 2017-12

Locations

US (8)