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PDT vs Peels for AKs

Sponsor
Northwestern University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04429308
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
11
Anticipated Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Photodynamic Therapy
  • Drug: Chemical Peels
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official 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
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Photodynamic Therapy

One upper arm will be exposed to blue light therapy

Procedure: Photodynamic Therapy
Photodynamic Therapy consists of (Levulan Kerastick (aminolevulinic acid HCL) topical solution, 20% + BLU-U Photodynamic Light Therapy)
Other Names:
  • PDT

    		•
    Active Comparator: Chemical Peels

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

    Drug: Chemical Peels
    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 Outcome Measures

    1. 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 Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwestern University Department of Dermatology Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Northwestern University

    Investigators

    • Principal Investigator: Murad Alam, MD, Northwestern University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Murad Alam, Professor of Dermatology, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT04429308
    Other Study ID Numbers:
    • STU00211723
    First Posted:
    Jun 12, 2020
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Keratosis, Actinic
    Keratosis

    Study Results

    No Results Posted as of Mar 4, 2022