NCT02594644

Brief Summary

The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

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

November 6, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2016

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

November 29, 2018

Completed
Last Updated

November 29, 2018

Status Verified

October 1, 2018

Enrollment Period

1.6 years

First QC Date

October 31, 2015

Results QC Date

November 3, 2017

Last Update Submit

October 30, 2018

Conditions

Keratosis, Actinic

Outcome Measures

Primary Outcomes (1)

  • Difference in the Percentage of Complete Clearance of the Actinic Keratoses

    The primary endpoint will be the difference in the percentage of complete clearance of the actinic keratoses as an intraindividual comparison between the treatment groups.

    Baseline, 2 Months

Secondary Outcomes (1)

  • Visual Analog Pain Scale

    Immediately Post-Treatment

Study Arms (2)

10-minute Incubation with Microneedle Roller & Sham

EXPERIMENTAL

10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.

Device: Microneedle RollerDrug: Aminolevulinic AcidRadiation: Blue Light

20-minute Incubation with Microneedle Roller & Sham

EXPERIMENTAL

20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.

Device: Microneedle RollerDrug: Aminolevulinic AcidRadiation: Blue Light

Interventions

Microneedle RollerDEVICE

The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 650 micrometers in length.

10-minute Incubation with Microneedle Roller & Sham20-minute Incubation with Microneedle Roller & Sham
Aminolevulinic AcidDRUG

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

10-minute Incubation with Microneedle Roller & Sham20-minute Incubation with Microneedle Roller & Sham
Blue LightRADIATION

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

10-minute Incubation with Microneedle Roller & Sham20-minute Incubation with Microneedle Roller & Sham

Eligibility Criteria

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

You may qualify if:

  • years of age and older
  • Subjects has actinic keratoses and qualifies for photodynamic therapy

You may not qualify if:

  • Subjects who smoke
  • Subjects who have a photosensitizing condition such as lupus, porphyria, or similar condition
  • Subjects who have established allergy to topical ALA
  • Subjects who have had a documented nonmelanoma skin cancer on the face over the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California-Davis, Department of Dermatology

Sacramento, California, 95816, United States

Location

Related Publications (1)

  • Petukhova TA, Hassoun LA, Foolad N, Barath M, Sivamani RK. Effect of Expedited Microneedle-Assisted Photodynamic Therapy for Field Treatment of Actinic Keratoses: A Randomized Clinical Trial. JAMA Dermatol. 2017 Jul 1;153(7):637-643. doi: 10.1001/jamadermatol.2017.0849.

    PMID: 28514458DERIVED

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
Tatyana Petukhova MD
Organization
UC Davis Department of Dermatology
tpetukhova@ucdavis.edu

Study Officials

  • Raja Sivamani, M.D.

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

October 31, 2015

First Posted

November 3, 2015

Study Start

November 6, 2014

Primary Completion

June 22, 2016

Study Completion

June 22, 2016

Last Updated

November 29, 2018

Results First Posted

November 29, 2018

Record last verified: 2018-10

Locations

US(1)