Photodynamic Therapy Incubation Times for Actinic Keratosis

A Randomized Controlled Trial Evaluating 5-aminolevulinic Acid Photodynamic Therapy With Different Incubation Times for the Treatment of Actinic Keratosis

This is a randomized clinical trial evaluating blue light 5-aminolevulinic acid (ALA) photodynamic therapy with different incubation times for the treatment of actinic keratosis.

Subjects who are interested in participating, currently living in the Chicago metropolitan area, and meet inclusion and exclusion criteria will be enrolled in the study. Subjects will be randomized to either 1) zero time ALA incubation or 2) 1 hour ALA incubation. Demographic and health data will be collected prior to treatment initiation. Three visits will be conducted: screening, treatment, and follow up visit at 8 weeks.

This study is a pilot study designed to determine feasibility of this procedure.

Study Overview

• Status: Active, not recruiting
• Conditions: Actinic Keratoses
• Intervention / Treatment: Drug: ALA (5-aminolevulinic acid); Device: Blue light therapy

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine, Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Subjects who have been diagnosed with actinic keratosis.
2. Subjects who by the investigator deem to be suitable for photodynamic therapy of the face or scalp.
3. Males or females ≥ 18 years old
4. Fitzpatrick skin types I-VI
5. Subjects are in good health as judged by the investigator.
6. Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.

Exclusion criteria:

1. Subjects who by the investigator are not suitable for photodynamic therapy.
2. Lesions suspicious or proven for skin cancer
3. History of 2 or more ALA- PDT treatments within the past 6 months.
4. Use of keratolytics within 2 days of initiation of treatment (e.g., >5% urea, glycolic acid, lactic acid, salicyclic acid)
5. Cryotherapy within the past 2 weeks.
6. Topical retinoids within the past 4 weeks
7. Procedures, such as microdermabrasion, ablative lasers, ALA-PDT, chemical peels, 5-fluorouraci, diclofenac, imiquimod within the past 8 weeks
8. Systemic retinoids within the past 6 months
9. Pregnant or breast feeding
10. Uncooperative subjects or subjects with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
11. Subjects who are unable to understand the protocol or give informed consent.
12. Subjects who in the opinion of the investigator are not suitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zero incubation with ALA (5-aminolevulinic acid); Subjects will receive zero time of incubation with ALA (5-aminolevulinic acid) before photodynamic blue light therapy.	Drug: ALA (5-aminolevulinic acid); ALA (5-aminolevulinic acid) will be applied to subjects' skin for either zero time incubation or one hour incubation; Other Names: Levulon kerastick; Device: Blue light therapy; Subjects will be exposed to blue light; Other Names: BLU-U® Blue Light Photodynamic Therapy Illuminator
Experimental: One hour incubation with ALA (5-aminolevulinic acid); Subjects will receive one hour of incubation with ALA (5-aminolevulinic acid) before photodynamic blue light therapy.	Drug: ALA (5-aminolevulinic acid); ALA (5-aminolevulinic acid) will be applied to subjects' skin for either zero time incubation or one hour incubation; Other Names: Levulon kerastick; Device: Blue light therapy; Subjects will be exposed to blue light; Other Names: BLU-U® Blue Light Photodynamic Therapy Illuminator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of Actinic Keratosis (AK) lesions	The number of AK lesions will be counted by a live, blinded assessor at baseline and at Week 8 follow-up visit.	Baseline and 8 Weeks

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Murad Alam, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 24, 2017
• First Submitted That Met QC Criteria: February 24, 2017
• First Posted (Actual): February 28, 2017

Study Record Updates

• Last Update Posted (Actual): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Photosensitizing Agents; Dermatologic Agents; Aminolevulinic Acid
• Other Study ID Numbers: STU00204459

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No