PDT vs Peels for Treatment of Actinic Keratoses
ConditionActinic Keratoses
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
>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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Photodynamic Therapy
Procedure/SurgeryPhotodynamic Therapy consists of (Levulan Kerastick (aminolevulinic acid HCL) topical solution, 20% + BLU-U Photodynamic Light Therapy)
Chemical Peels
DrugChemical 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
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Photodynamic TherapyActive comparator 1 intervention
Group B: Chemical PeelsActive comparator 1 intervention
Trial outcomes
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.
Time frame
2-8 weeks after treatmentsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: