PDT vs Peels for Treatment of Actinic Keratoses

NCT04429308 | Not Yet Recruiting Phase 2

• 1 other identifier: STU00211723
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Actinic Keratoses

Outcome Measures

Primary Outcomes (1)

• Percentage of total AKs cleared

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

  2-8 weeks after treatments

Study Arms (2)

Photodynamic Therapy

ACTIVE COMPARATOR

One upper arm will be exposed to blue light therapy

Procedure: Photodynamic Therapy

Chemical Peels

ACTIVE COMPARATOR

One upper arm will be exposed to Jessner's Solution AND 35% Trichloroacetic acid peel

Drug: Chemical Peels

Interventions

Photodynamic Therapy PROCEDURE

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

Also known as: PDT

Photodynamic 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

Chemical Peels

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Photochemotherapy; 1-phenyl-3,3-dimethyltriazene; Chemexfoliation

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Cosmetic Techniques; Dermatologic Surgical Procedures; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandra Onate, M.S.

CONTACT

onate@northwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)