Photodynamic Therapy Incubation Times for Actinic Keratosis

NCT03066843 | Active Not Recruiting DMC

• 1 other identifier: STU00204459
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Actinic Keratoses

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Zero incubation with ALA (5-aminolevulinic acid)

EXPERIMENTAL

Subjects will receive zero time of incubation with ALA (5-aminolevulinic acid) before photodynamic blue light therapy.

Drug: ALA (5-aminolevulinic acid); Device: Blue light therapy

One hour incubation with ALA (5-aminolevulinic acid)

EXPERIMENTAL

Subjects will receive one hour of incubation with ALA (5-aminolevulinic acid) before photodynamic blue light therapy.

Drug: ALA (5-aminolevulinic acid); Device: Blue light therapy

Interventions

ALA (5-aminolevulinic acid) DRUG

ALA (5-aminolevulinic acid) will be applied to subjects' skin for either zero time incubation or one hour incubation

Also known as: Levulon kerastick

One hour incubation with ALA (5-aminolevulinic acid); Zero incubation with ALA (5-aminolevulinic acid)

Blue light therapy DEVICE

Subjects will be exposed to blue light

Also known as: BLU-U® Blue Light Photodynamic Therapy Illuminator

One hour incubation with ALA (5-aminolevulinic acid); Zero incubation with ALA (5-aminolevulinic acid)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have been diagnosed with actinic keratosis.
• Subjects who by the investigator deem to be suitable for photodynamic therapy of the face or scalp.
• Males or females ≥ 18 years old
• Fitzpatrick skin types I-VI
• Subjects are in good health as judged by the investigator.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Aminolevulinic Acid; Phototherapy

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Therapeutics

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: February 28, 2017
• Study Start: March 1, 2017
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)