Photodynamic Therapy for Actinic Keratosis

Recruiting in Palo Alto (17 mi)

Overseen byMurad Alam, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Northwestern University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

I can understand and agree to participate in the study.

Your skin type falls within the Fitzpatrick scale categories I to VI.

I have been diagnosed with actinic keratosis.

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Exclusion 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.

Pregnant or breast feeding

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Treatment Details

Interventions

ALA (5-aminolevulinic acid) (Photosensitizer)
Blue light therapy (Procedure)

Trial OverviewThe 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.

Participant Groups

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.