NCT01458587

Brief Summary

The purpose of this study is to determine if Levulan PDT is safe and effective in the treatment of actinic keratoses on the upper arms and hands.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2011

Completed
7 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
7 months until next milestone

Results Posted

Study results publicly available

February 4, 2013

Completed
Last Updated

March 14, 2013

Status Verified

March 1, 2013

Enrollment Period

8 months

First QC Date

October 21, 2011

Results QC Date

December 21, 2012

Last Update Submit

March 12, 2013

Conditions

Keratosis, Actinic

Keywords

Actinic keratosis

Outcome Measures

Primary Outcomes (1)

  • Lesion Clearance Rate

    Clearance rate for all lesions

    Week 12

Secondary Outcomes (38)

  • Lesion Clearance Rate

    Week 8

  • Complete Clearance Rate

    Week 8

  • Complete Clearance Rate

    Week 12

  • Partial Clearance Rate

    Baseline and Week 8

  • Partial Clearance Rate

    Baseline and Week 12

  • +33 more secondary outcomes

Study Arms (2)

ALA

EXPERIMENTAL
Drug: Aminolevulinic Acid PDT (ALA)

Vehicle

PLACEBO COMPARATOR
Drug: Vehicle PDT (VEH)

Interventions

Aminolevulinic Acid PDT (ALA)DRUG

20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light

Also known as: Levulan Kerastick
ALA
Vehicle PDT (VEH)DRUG

Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light

Vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 4 Grade 1/2 AKs on each upper extremity

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
  • 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 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Park Avenue Dermatology, PA

Orange Park, Florida, 32073, United States

Location

DermResearch, Inc

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Levulinic AcidsKeto AcidsCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Anna Houlihan
Organization
DUSA Pharmaceuticals, Inc.
houlihana@dusapharma.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

October 21, 2011

First Posted

October 25, 2011

Study Start

November 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

March 14, 2013

Results First Posted

February 4, 2013

Record last verified: 2013-03

Locations

US(3)