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Photodynamic Therapy Incubation Times for Actinic Keratosis

Primary Purpose

Actinic Keratoses

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ALA (5-aminolevulinic acid)

Blue light therapy

About this trial

This is an interventional treatment trial for Actinic Keratoses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Northwestern University Feinberg School of Medicine, Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Zero incubation with ALA (5-aminolevulinic acid)

One hour incubation with ALA (5-aminolevulinic acid)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03066843

First Posted

February 24, 2017

Last Updated

February 17, 2023

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT03066843

Brief Title

Photodynamic Therapy Incubation Times for Actinic Keratosis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Actinic Keratoses

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Zero incubation with ALA (5-aminolevulinic acid)

Arm Type

Experimental

Arm Description

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

Arm Title

One hour incubation with ALA (5-aminolevulinic acid)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

ALA (5-aminolevulinic acid)

Other Intervention Name(s)

Levulon kerastick

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Blue light therapy

Other Intervention Name(s)

BLU-U® Blue Light Photodynamic Therapy Illuminator

Intervention Description

Subjects will be exposed to blue light

Primary Outcome Measure Information:

Title

Change in number of Actinic Keratosis (AK) lesions

Description

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

Time Frame

Baseline and 8 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Murad Alam, MD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University Feinberg School of Medicine, Department of Dermatology

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Photodynamic Therapy Incubation Times for Actinic Keratosis

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