NCT03327831

Brief Summary

Photodynamic therapy is an effective treatment for actinic keratoses. In the United States topical aminolevulinic acid (ALA) is approved as a photosensitizing agent for this treatment, and it has traditionally been activated with the use of an in-office artificial light source. This clinical trial seeks to measure the safety and efficacy of using natural sunlight to activate the ALA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2015

Typical duration for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

June 27, 2024

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

1.8 years

First QC Date

October 23, 2015

Results QC Date

October 30, 2018

Last Update Submit

June 25, 2024

Conditions

Actinic Keratosis

Keywords

aminolevulinic acidpdtphotodynamic therapyPhotochemotherapy

Outcome Measures

Primary Outcomes (1)

  • Percent Change in the Number of Actinic Keratoses

    Percent change in number of actinic keratoses at 6 months

    0 (baseline) and 6 months

Secondary Outcomes (1)

  • Number of Participants With Adverse Events

    2 days

Study Arms (1)

Aminolevulinic Acid with daylight photodynamic therapy arm

EXPERIMENTAL

This study has a single, open label treatment arm. Patients will have topical aminolevulinic acid applied to the actinic keratoses in the treatment area (face/scalp) and will spend 2 hours outdoors in the shade to activate the medication. The patient then follow up in clinic 3 months and 6 months after their treatment to have the number of actinic keratoses counted.

Drug: Aminolevulinic Acid

Interventions

Aminolevulinic AcidDRUG

Topical application followed by activation by ambient sunlight

Also known as: Kerastick
Aminolevulinic Acid with daylight photodynamic therapy arm

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of \>10 actinic keratoses on head and neck
  • Age ≥ 18 years (Because no dosing or adverse event data are currently available on the use of topical aminolevulinic acid in patients \<18 years of age, children are excluded from this study)
  • Ability to understand and the willingness to sign a written informed consent.

You may not qualify if:

  • Patients currently undergoing anti-neoplastic therapy including but not limited to the following:
  • Topical imiquimod
  • Topical 5-fluorouracil
  • Topical ingenol mebutate
  • Topical diclofenac
  • Topical retinoids
  • Oral acitretin
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid
  • Patients with a known photosensitivity disorder including but not limited to porphyria, lupus, polymorphous light eruption, or immunobullous disease.
  • Patients taking known photosensitizing medications including but not limited to griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines.
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Irvine

Irvine, California, 92697-2400, 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
Christopher Zachary
Organization
UC Irvine
czachary@uci.edu
949-824-5515

Study Officials

  • Christopher B Zachary, MBBS. FRC[

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 23, 2015

First Posted

October 31, 2017

Study Start

April 1, 2015

Primary Completion

February 1, 2017

Study Completion

July 1, 2017

Last Updated

June 27, 2024

Results First Posted

June 27, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)