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

Sponsor
Wright State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03906253
Collaborator
(none)
72
Enrollment
1
Location
2
Arms
118.7
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is following up on previous studies that have demonstrated that geriatric subjects respond different to ultraviolet B (UVB) light than young subjects. The treatment of geriatric skin with dermal rejuvenation therapies (dermabrasion, fractionated laser resurfacing) restores the appropriate UVB response. Ongoing studies have tested the ability of fractionated laser resurfacing (FLR) to assess how long this wounding effect lasts-and have found that this appears to be a durable response which lasts for at least two years. The findings that FLR protects geriatric skin at two years is the impetus for this study.

This study is an interventional study to assess if FLR treatment of one forearm of geriatric subjects with multiple actinic keratosis will result in the short-term removal of actinic keratosis, and the long-term decrease in levels of future actinic keratosis and other non-melanoma skin cancers in comparison to the untreated arm.

Study length and visit: The first part of the study is completed in 1 day then there are follow up visits at 90 days and every 6 months for 5 years.

Condition or Disease Intervention/Treatment Phase
  • Device: Fractionated Laser Resurfacing
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effectiveness of Fractionated Laser Resurfacing to Protect Geriatric Skin From Actinic Neoplasia
Actual Study Start Date :
Jan 10, 2018
Anticipated Primary Completion Date :
Dec 1, 2027
Anticipated Study Completion Date :
Dec 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Factionated Laser Resurfacing - Right Arm

Right forearm treatment of fractionated laser resurfacing.

Device: Fractionated Laser Resurfacing
A rejuvenating laser that makes tiny holes in the very superficial part of the skin.
Experimental: Factionated Laser Resurfacing - Left Arm

Left forearm treatment of fractionated laser resurfacing.

Device: Fractionated Laser Resurfacing
A rejuvenating laser that makes tiny holes in the very superficial part of the skin.

Outcome Measures

Primary Outcome Measures

  1. Change From Baseline in the Number of Actinic Keratosis due to FLR treatment. [up to 5 years]

    Investigator will assess the number of actinic keratosis on both forearms.

  2. Change From Baseline in the Number Non-Melanoma Skin Cancers due to FLR treatment. [up to 5 years]

    Investigator will assess the number of actinic keratosis on both forearms.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Diagnosed with Actinic Keratosis within the past 6 months

  • At least 60 years of age, or older

  • Ability to comprehend procedures and risks versus benefits

  • Able to provide Informed Consent

  • Fair Skin (Fitzpatrick Type I or II)

  • Possess both Right and Left Forearms

Exclusion Criteria:

  • Uncontrolled Diabetes Mellitus

  • Not able to comprehend procedures or risks versus benefits

  • Pregnant or nursing

  • Large tattoos on forearms

  • History of abnormal healing or scarring (i.e., keloids)

  • Any disease that gets worse while in the sun

  • Use of topical or oral anti-inflammatory medication or steroids

  • Allergy to lidocaine

  • Current use of photosensitizing medication

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dayton VA Medical Center Dayton Ohio United States 45428

Sponsors and Collaborators

  • Wright State University

Investigators

  • Principal Investigator: Jeffrey B Travers, MD, PhD, Wright State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wright State University
ClinicalTrials.gov Identifier:
NCT03906253
Other Study ID Numbers:
  • 06438
First Posted:
Apr 8, 2019
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Keratosis, Actinic
Keratosis

Study Results

No Results Posted as of Aug 22, 2022