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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
Must not have
Use of topical or oral anti-inflammatory medication or steroids
Current use of photosensitizing medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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
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I am 60 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am using anti-inflammatory medication or steroids.
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I am currently taking medication that increases my sensitivity to light.
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My diabetes is not well-managed.
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My condition worsens with sun exposure.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active 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

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
46 Previous Clinical Trials
55,236 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
~26 spots leftby Dec 2028
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