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Photosensitizer
Photodynamic Therapy for Actinic Keratosis
N/A
Waitlist Available
Led By Murad Alam, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects who have been diagnosed with actinic keratosis
Be older than 18 years old
Must not have
History of 2 or more ALA-PDT treatments within the past 6 months
Lesions suspicious or proven for skin cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 8 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new way to treat actinic keratosis using light. People in the Chicago area who are interested and meet the requirements are randomly chosen to either have no incubation time with the 5-aminolevulinic acid or 1 hour. There are 3 visits total, and this study is to see if the new method is possible.
Who is the study for?
This trial is for individuals in the Chicago area with actinic keratosis, suitable for photodynamic therapy on face or scalp. Participants must be adults in good health and able to consent. Excluded are those using certain skin treatments recently, pregnant or breastfeeding women, and anyone unsuitable as per investigator's judgment.
What is being tested?
The study tests blue light ALA photodynamic therapy for actinic keratosis with different prep times: no incubation versus a 1-hour wait before treatment. It's a randomized pilot study to assess the procedure's feasibility over three visits including screening, treatment, and an 8-week follow-up.
What are the potential side effects?
While not explicitly listed here, typical side effects of ALA photodynamic therapy may include redness, swelling at the treated area, stinging or burning sensations during treatment, potential crusting post-treatment, and sensitivity to sunlight.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with actinic keratosis.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had 2 or more ALA-PDT treatments in the last 6 months.
Select...
I have skin lesions that may be cancerous.
Select...
I understand the study and can give my consent.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in number of Actinic Keratosis (AK) lesions
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Zero incubation with ALA (5-aminolevulinic acid)Experimental Treatment2 Interventions
Subjects will receive zero time of incubation with ALA (5-aminolevulinic acid) before photodynamic blue light therapy.
Group II: One hour incubation with ALA (5-aminolevulinic acid)Experimental Treatment2 Interventions
Subjects will receive one hour of incubation with ALA (5-aminolevulinic acid) before photodynamic blue light therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blue light therapy
2019
N/A
~20
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,652 Previous Clinical Trials
961,455 Total Patients Enrolled
Murad Alam, MDPrincipal InvestigatorNorthwestern University
69 Previous Clinical Trials
2,520 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had 2 or more ALA-PDT treatments in the last 6 months.I have not had cryotherapy in the last 2 weeks.I can understand and agree to participate in the study.I have not used topical retinoids in the last 4 weeks.I haven't taken any retinoid medications in the last 6 months.Your skin type falls within the Fitzpatrick scale categories I to VI.I have skin lesions that may be cancerous.I haven't used strong skin peeling products in the last 2 days.I haven't had skin treatments like peels or lasers in the last 8 weeks.I understand the study and can give my consent.I have been diagnosed with actinic keratosis.I am 18 years old or older.My doctor thinks I am a good candidate for light therapy on my face or scalp.
Research Study Groups:
This trial has the following groups:- Group 1: Zero incubation with ALA (5-aminolevulinic acid)
- Group 2: One hour incubation with ALA (5-aminolevulinic acid)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.