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Procedure

Fractionated Laser Resurfacing for Actinic Keratosis and Skin Cancer Prevention

N/A

Recruiting

Led By Jeffrey B Travers, MD, PhD

Research Sponsored by Jeffrey B. Travers, MD, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 60 years of age, or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing if a fractionated laser resurfacing treatment can help to remove actinic keratosis, and also if it can help to reduce the levels of future actinic keratosis and other non-melanoma skin cancers, in comparison to an untreated arm. The study length is 5 years, with the first part completed in 1 day, and follow up visits at 90 days and every 6 months.

Who is the study for?

This trial is for people aged 60 or older with a recent diagnosis of Actinic Keratosis, fair skin (Fitzpatrick Type I or II), and both forearms intact. They must understand the study's procedures and risks/benefits, and be able to consent. Excluded are those allergic to lidocaine, on photosensitizing meds, pregnant/nursing women, users of anti-inflammatory drugs/steroids, uncontrolled diabetics, individuals prone to abnormal scarring or worsening of conditions in sunlight.Check my eligibility

What is being tested?

The study tests if Fractionated Laser Resurfacing (FLR) on one forearm can remove Actinic Keratosis short-term and reduce future non-melanoma skin cancers long-term compared to an untreated arm. The initial treatment takes one day with follow-ups at 90 days then every six months for five years.See study design

What are the potential side effects?

Potential side effects from FLR may include redness, swelling at the treatment site, changes in skin pigmentation, discomfort during the procedure despite local anesthesia (lidocaine), potential scarring including keloid formation especially in predisposed individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 60 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change From Baseline in the Number Non-Melanoma Skin Cancers due to FLR treatment.

Change From Baseline in the Number of Actinic Keratosis due to FLR treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Factionated Laser Resurfacing - Right ArmExperimental Treatment1 Intervention

Right forearm treatment of fractionated laser resurfacing.

Group II: Factionated Laser Resurfacing - Left ArmExperimental Treatment1 Intervention

Left forearm treatment of fractionated laser resurfacing.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fractionated Laser Resurfacing

2007

N/A

~20

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jeffrey B. Travers, MD, PhDLead Sponsor

4 Previous Clinical Trials

84 Total Patients Enrolled

Wright State UniversityLead Sponsor

41 Previous Clinical Trials

54,810 Total Patients Enrolled

Jeffrey B Travers, MD, PhDPrincipal InvestigatorWright State University

9 Previous Clinical Trials

188 Total Patients Enrolled

Media Library

Actinic Keratosis Research Study Groups: Factionated Laser Resurfacing - Left Arm, Factionated Laser Resurfacing - Right Arm

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the uppermost limit of participants in this experiment?

"Indeed, the information available on clinicaltrials.gov verifies that this trial is in search of participants. It was published online on January 10th 2018 and modified most recently on August 17th 2022. To date, 72 individuals are required at a single medical centre for enrolment."

Answered by AI

Is this research program in need of participants at the moment?

"The most recent evidence on clinicaltrials.gov specifies that this trial is still enrolling participants, having been initially posted back in January 10th 2018 and last modified on August 17th 2022."

Answered by AI

Recent research and studies

Lasers in Surgery and MedicineJournal

Single Ablative Fractional Resurfacing Laser Treatment for Forearm Actinic Keratoses: 6‐month Follow‐up Data from an Intrapatient Comparison Between Treated and Untreated Sites

Chen, Roy, Jeffrey J. Wargo, Amy Williams, Elizabeth Cates, Dan F. Spandau, Christina Knisely, and Jeffrey B. Travers. 2019. “Single Ablative Fractional Resurfacing Laser Treatment for Forearm Actinic Keratoses: 6‐month Follow‐up Data from an Intrapatient Comparison Between Treated and Untreated Sites”. Lasers in Surgery and Medicine. Wiley. doi:10.1002/lsm.23175.

Journal of Clinical InvestigationJournal

Randomized Controlled Trial of Fractionated Laser Resurfacing on Aged Skin as Prophylaxis Against Actinic Neoplasia

Spandau, Dan F., Roy Chen, Jeffrey J. Wargo, Craig A. Rohan, David Southern, Angela Zhang, Mathew Loesch, et al.. 2021. “Randomized Controlled Trial of Fractionated Laser Resurfacing on Aged Skin as Prophylaxis Against Actinic Neoplasia”. Journal of Clinical Investigation. American Society for Clinical Investigation. doi:10.1172/jci150972.

Journal of Clinical InvestigationJournal

Randomized Controlled Trial of Fractionated Laser Resurfacing on Aged Skin as Prophylaxis Against Actinic Neoplasia

clinicaltrials.govStudy

Effectiveness of Fractionated Laser Resurfacing to Protect Geriatric Skin From Actinic Neoplasia