The Preventive Role of Fractionated Laser Resurfacing Against Actinic Neoplasia in an At-Risk Geriatric Population
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorWright State University
About this trial
The purpose of this study is to determine if the Fractionated Laser Resurfacing (FLR) procedure can protect one forearm/wrist from precancerous actinic keratosis (AKs) as well as prevent skin cancer in older subjects with active AKs. This study builds on a similar study ongoing at the Dayton Veterans Administration dermatology clinic. This study is also testing if a photograph of the skin can be used to predict where the AKs and an skin cancers will form.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult Males and Females aged 60 and older
Have at least 5 AKs on each forearm/wrist, but no more than 10 to allow for easy monitoring
Skin type fair (Fitzpatrick I-II)
Females must be post-menopausal and not be on systemic hormone replacement therapy
Disqualifiers
More than 10 AKs on an extremity
AKs that are large (2-3+, hyperkeratotic grade 3 lesions)
AKs that are very thick (>3 mm)
Medical history of diabetes
Trial design
Design model
Parallel
Treatments tested in this trial
Fractionated Laser Resurfacing
DeviceA rejuvenating laser that makes tiny holes in the very superficial part of the skin.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Fractionated Laser Resurfacing - Right ArmExperimental treatment 1 intervention
Group B: Fractionated Laser Resurfacing - Left ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in the number of actinic keratosis due to FLR treatment.
Investigator will assess the number of actinic keratosis on both forearms at each visit.
Time frame
Up to 5 years2
Change from baseline in the number of non-melanoma skin cancers due to FLR treatment.
Investigator will assess the number of actinic keratosis on both forearms at each visit.
Time frame
Up to 5 yearsSecondary outcomes
1
Skin dysplasia change, in regards to actinic keratosis, from baseline due to FLR treatment.
Investigator will use the scattering patterns of light to assess the number of actinic keratosis on both forearms at each visit.
Time frame
Up to 5 years2
Skin dysplasia change, in regards to non-melanoma skin cancer, from baseline due to FLR treatment.
Investigator will use the scattering patterns of light to assess the number of actinic keratosis on both forearms at each visit.
Time frame
Up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov