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Procedure

Laser Resurfacing for Precancerous Skin Lesions

N/A
Recruiting
Led By Jeffrey Travers, MD, PhD
Research Sponsored by Wright State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult Males and Females aged 60 and older
Females must be post-menopausal and not be on systemic hormone replacement therapy
Must not have
Medical history of diabetes
AKs that are large (2-3+, hyperkeratotic grade 3 lesions)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to investigate whether a specific laser treatment can help prevent precancerous skin lesions and skin cancer in older individuals with existing precancerous lesions. The study will also explore if taking photographs of

Who is the study for?
This trial is for older adults with active precancerous skin lesions known as actinic keratosis. Participants should have a history of these lesions and be at risk for developing skin cancer. Specific eligibility criteria are not provided, but typically include being in good health and meeting certain medical parameters.
What is being tested?
The study is examining whether Fractionated Laser Resurfacing (FLR) can prevent the formation of actinic keratosis and potentially stop skin cancer from developing on one forearm/wrist. It also explores if photographs can predict lesion development.
What are the potential side effects?
While specific side effects are not listed, laser resurfacing procedures may commonly result in redness, swelling, itching, and changes in skin coloration. More serious side effects could include scarring or infection.

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.
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I am a post-menopausal woman not on hormone replacement therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of diabetes.
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I have large, severe skin lesions.
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My skin growth is thicker than 3 mm.
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I have a history of poor wound healing or scarring.
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I have more than 10 skin growths on one of my arms or legs.

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 of actinic keratosis due to FLR treatment.
Change from baseline in the number of non-melanoma skin cancers due to FLR treatment.
Secondary study objectives
Skin dysplasia change, in regards to actinic keratosis, from baseline due to FLR treatment.
Skin dysplasia change, in regards to non-melanoma skin cancer, from baseline 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: Fractionated Laser Resurfacing - Right ArmExperimental Treatment1 Intervention
Right forearm treatment of fractionated laser resurfacing.
Group II: Fractionated 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?

Wright State UniversityLead Sponsor
45 Previous Clinical Trials
55,028 Total Patients Enrolled
Jeffrey Travers, MD, PhDPrincipal InvestigatorWright State University
1 Previous Clinical Trials
12 Total Patients Enrolled
~53 spots leftby Dec 2031
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