PDT vs Peels for Treatment of Actinic Keratoses

NCT04429308 — Phase 2, Not yet recruiting, 60 participants, Northwestern University

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PDT Versus the Combination of Jessner's Solution and 35% TCA for Treatment of Actinic Keratoses on Upper Extremities: A Randomized Controlled Split-arm Trial

Registry	NCT04429308
Status	Not yet recruiting
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	60 (Estimated)
Sponsor	Northwestern University (Other)
Conditions	Actinic Keratoses
Interventions	Photodynamic Therapy, Chemical Peels (Procedure, drug)
Dates	start 2026-08-01 (estimated), primary completion 2027-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2020-06-12, last updated 2026-07-01
Locations	1 site in United States

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Photodynamic Therapy	Active comparator	Procedure: Photodynamic Therapy	One upper arm will be exposed to blue light therapy
Chemical Peels	Active comparator	Drug: Chemical Peels	One upper arm will be exposed to Jessner's Solution AND 35% Trichloroacetic acid peel

Photodynamic Therapy (Procedure), also known as PDT: 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

+Outcome measures

Primary outcomes

Percentage of total AKs cleared [2-8 weeks after treatments]: Percentage of total AKs cleared will be calculated by counting the number of AKs before treatment and 2-8 weeks after treatments.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

1. >18 years of age
2. Interested in receiving treatment for actinic keratoses on the bilateral upper arms
3. In good general health as assessed by the investigator
4. Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

Exclusion Criteria:

1. Patient pregnant or nursing
2. Patient with extensive concurrent skin conditions (such as eczema, psoriasis, etc) on upper extremities that would interfere with treatment as determined by the treating physician
3. Subject unwilling to sign an IRB approved consent form
4. Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible

+Locations (1)

Facility	City	Country	Status
Northwestern University Department of Dermatology	Chicago, Illinois	United States

+Investigators

Murad Alam, MD, Principal investigator, Northwestern University