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
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratoses
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.
Sites / Locations
- Northwestern University Feinberg School of Medicine, Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
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
No
Studies a U.S. FDA-regulated Device Product
No
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
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
No
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Photodynamic Therapy Incubation Times for Actinic Keratosis
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