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NCT Number: NCT04429308

PDT vs Peels for Treatment of Actinic Keratoses

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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Key information

Conditions

Actinic Keratoses Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location contact

Murad Alam, MD

CONTACT

[email protected]

312-695-6785

Murad Alam, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Patient pregnant or nursing
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
Subject unwilling to sign an IRB approved consent form
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

Treatment and study plan

Photodynamic Therapy

Procedure

Photodynamic Therapy consists of (Levulan Kerastick (aminolevulinic acid HCL) topical solution, 20% + BLU-U Photodynamic Light Therapy)

Other names: PDT

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

Primary outcomes

Percentage of total AKs cleared

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alejandra Onate, M.S.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jun 12, 2020
Registry last updated: Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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