PDT vs Peels for Treatment of Actinic Keratoses

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT04429308
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Actinic Keratoses

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Photodynamic Therapy — PROCEDURE
    Photodynamic Therapy consists of (Levulan Kerastick (aminolevulinic acid HCL) topical solution, 20% + BLU-U Photodynamic Light Therapy)
  • Chemical Peels — DRUG
    Chemical peels consists of a combination of Jessner's Solution: Composed of Salicylic Acid (14%), Medical Grade Lactic Acid (14%), Medical Grade Resorcinol (14%), Denatured Ethyl Alcohol AND 35% Trichloroacetic acid peels

Study Details

The purpose of this study is to to compare photodynamic therapy (PDT) versus the combination of Jessner's solution and 35% trichloroacetic acid (TCA) chemical peels for the treatment of actinic keratoses on upper extremities. This is a randomized clinical trial. Approximately 60 participants with actinic keratoses on both upper arms will be randomized to have one arm receive photodynamic therapy, while the contralateral arm receives Jessner's solution followed immediately by 35% TCA. AKs will be counted before treatment and 2-8 weeks after treatment. This study is a pilot study designed to determine the feasibility of this procedure. Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.

Key Dates

Start date
Aug 31, 2025
Status verified
May 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Photodynamic Therapy
    One upper arm will be exposed to blue light therapy
  • Active Comparator: Chemical Peels
    One upper arm will be exposed to Jessner's Solution AND 35% Trichloroacetic acid peel

Primary Outcome Measure

Percentage of total AKs cleared [ Time Frame: 2-8 weeks after treatments ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern University Department of DermatologyChicagoIllinois60611
Murad Alam, MD
[email protected]
312-695-6785
Murad Alam, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Northwestern University Department of Dermatology· Chicago, IL

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