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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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~baseline and 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 8 weeks for reporting.

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
1,645 Previous Clinical Trials
958,534 Total Patients Enrolled
Murad Alam, MDPrincipal InvestigatorNorthwestern University
69 Previous Clinical Trials
2,520 Total Patients Enrolled

Media Library

ALA (5-aminolevulinic acid) (Photosensitizer) Clinical Trial Eligibility Overview. Trial Name: NCT03066843 — N/A
Actinic Keratosis Research Study Groups: Zero incubation with ALA (5-aminolevulinic acid), One hour incubation with ALA (5-aminolevulinic acid)
Actinic Keratosis Clinical Trial 2023: ALA (5-aminolevulinic acid) Highlights & Side Effects. Trial Name: NCT03066843 — N/A
ALA (5-aminolevulinic acid) (Photosensitizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03066843 — N/A
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