PDT vs Peels for Treatment of Actinic Keratoses

Phase 2

Not yet recruiting

• Conditions: Actinic Keratoses
• Interventions: Procedure: Photodynamic Therapy; Drug: Chemical Peels

• Registration Number: NCT04429308
• Lead Sponsor: Northwestern University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-10
• Study First Posted: 2020-06-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15
• Study Start: 2025-01
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Photodynamic Therapy	Photodynamic Therapy	One upper arm will be exposed to blue light therapy
Chemical Peels	Chemical Peels	One upper arm will be exposed to Jessner's Solution AND 35% Trichloroacetic acid peel

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Northwestern University Department of Dermatology; 🇺🇸 Chicago, Illinois, United States