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OpenTrials
Completed

NCT Number: NCT03066843

Photodynamic Therapy Incubation Times for 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

ALA (5-aminolevulinic acid)

Drug

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

Other names: Levulon kerastick

Blue Light Therapy

Device

Subjects will be exposed to blue light

Other names: BLU-U® Blue Light Photodynamic Therapy Illuminator

Primary outcomes

  1. Change in number of Actinic Keratosis (AK) lesions

    Time frame: Baseline and 8 Weeks

    The number of AK lesions will be counted by a live, blinded assessor at baseline and at Week 8 follow-up visit.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Feb 28, 2017
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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