Back to resultsPDT vs Peels for AKs
Primary Purpose
Actinic Keratoses
Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Photodynamic Therapy
Chemical Peels
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratoses
Eligibility Criteria
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
Sites / Locations
- Northwestern University Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Photodynamic Therapy
Chemical Peels
Arm Description
One upper arm will be exposed to blue light therapy
One upper arm will be exposed to Jessner's Solution AND 35% Trichloroacetic acid peel
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04429308
Brief Title
PDT vs Peels for AKs
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratoses
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Photodynamic Therapy
Arm Type
Active Comparator
Arm Description
One upper arm will be exposed to blue light therapy
Arm Title
Chemical Peels
Arm Type
Active Comparator
Arm Description
One upper arm will be exposed to Jessner's Solution AND 35% Trichloroacetic acid peel
Intervention Type
Procedure
Intervention Name(s)
Photodynamic Therapy
Other Intervention Name(s)
PDT
Intervention Description
Photodynamic Therapy consists of (Levulan Kerastick (aminolevulinic acid HCL) topical solution, 20% + BLU-U Photodynamic Light Therapy)
Intervention Type
Drug
Intervention Name(s)
Chemical Peels
Intervention Description
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 Outcome Measure Information:
Title
Percentage of total AKs cleared
Description
Percentage of total AKs cleared will be calculated by counting the number of AKs before treatment and 2-8 weeks after treatments.
Time Frame
2-8 weeks after treatments
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandra Onate, M.S.
Email
onate@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Phone
312-695-6785
Email
m-alam@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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PDT vs Peels for AKs
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