NCT01812837

Brief Summary

The global aim of this study is to investigate how microneedles can facilitate the penetration and efficacy of photodynamic therapy in the treatment of actinic keratoses The specific aims are as follows:

  1. 1.Investigate whether pretreatment with microneedles enhances penetration of topical aminolevulinic acid (ALA) that is marketed as Levulan® Kerasticks by DUSA pharmaceuticals Inc.
  2. 2.Investigate whether pretreatment with microneedles can decrease the required incubation times of the topical ALA prior to exposure to blue light photodynamic therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 18, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

January 30, 2017

Completed
Last Updated

June 15, 2017

Status Verified

May 1, 2017

Enrollment Period

1.7 years

First QC Date

March 13, 2013

Results QC Date

December 2, 2016

Last Update Submit

May 24, 2017

Conditions

Actinic Keratosis

Keywords

actinic keratosismicroneedlesphotodynamic therapylevulanAminolevulinic acid

Outcome Measures

Primary Outcomes (1)

  • Actinic Keratoses Reduction Percent

    one month after treatment

Study Arms (4)

20 minutes incubation - with pretreatment

EXPERIMENTAL
Device: MicroneedleDrug: Aminolevulinic AcidRadiation: Blue light

40 minutes incubation - with pretreatment

EXPERIMENTAL
Device: MicroneedleDrug: Aminolevulinic AcidRadiation: Blue light

60 minutes incubation - with pretreatment

EXPERIMENTAL
Device: MicroneedleDrug: Aminolevulinic AcidRadiation: Blue light

60 minutes incubation - no pretreatment

SHAM COMPARATOR
Drug: Aminolevulinic AcidRadiation: Blue light

Interventions

MicroneedleDEVICE

The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.

Also known as: Microchannles
20 minutes incubation - with pretreatment40 minutes incubation - with pretreatment60 minutes incubation - with pretreatment
Aminolevulinic AcidDRUG

Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA

20 minutes incubation - with pretreatment40 minutes incubation - with pretreatment60 minutes incubation - no pretreatment60 minutes incubation - with pretreatment
Blue lightRADIATION

Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)

20 minutes incubation - with pretreatment40 minutes incubation - with pretreatment60 minutes incubation - no pretreatment60 minutes incubation - with pretreatment

Eligibility Criteria

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

You may qualify if:

  • Subjects who are 18 and older
  • Subjects who have at least 3 actinic keratoses on each side of the forehead
  • Subjects who signed an IRB approved informed consent

You may not qualify if:

  • Subjects who smoke
  • Subjects who have a photosensitizing condition such as lupus, porphyria, or similar condition.
  • Subjects who received a diagnosis of skin cancer on the face in past year
  • Subjects who received field treatment for actinic keratoses to the face in the past 60 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis, Dermatology

Sacramento, California, 95864, United States

Location

Related Links

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Aminolevulinic AcidBlue Light

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Levulinic AcidsKeto AcidsCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsLightElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaOptical PhenomenaRadiationRadiation, Nonionizing

Results Point of Contact

Title
Dr. Raja Sivamani
Organization
UC Davis
rksivamani@ucdavis.edu
9167035145

Study Officials

  • Raja K Sivamani, MD

    UC Davis

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2013

First Posted

March 18, 2013

Study Start

July 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

June 15, 2017

Results First Posted

January 30, 2017

Record last verified: 2017-05

Locations

US(1)