Therapeutic Induction of Dermal Remodeling in Veterans to Prevent Actinic Neoplasia Caused by Chronic Environmental Exposure to Ultraviolet Radiation
The investigators' previous studies demonstrate geriatric subject skin responds differently to ultraviolet B (UVB) light compared to young subject skin, which contribute to increased rates of nonmelanoma skin cancer (NMSC) and actinic keratosis (AK) development in geriatric populations. Previously, the investigators have shown that therapeutic dermal remodeling interventions (e.g., fractionated laser resurfacing and microneedling) can restore appropriate skin responses to UVB in geriatric skin. The investigators also demonstrated fractionated laser resurfacing (FLR) reduced rates of NMSC and AK development (compared to untreated control skin) in at risk geriatric subjects.
This interventional study will assess the ability of two therapeutic dermal remodeling therapies, microneedling and trichloroacetic acid chemical (TCA) peel, to impact NMSC and AK development in at risk geriatric subjects. Geriatric subjects will be enrolled into one of two study groups. In the first group, one arm will be treated with microneedling and the other arm will not be treated on day 1. In the second group, one arm will be treated with TCA peel and the other arm will not be treated on day 1. Subjects will subsequently be monitored for number of NMSC and AK on treated and untreated (control) forearms in each group. In addition to monitoring NMSC and AK development, subjects at the Richard L. Roudebush VAMC will undergo skin punch biopsy at one of their follow up visits for microscopic and molecular analyses of treated and untreated skin.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Matthew J Turner, MD
- Telefonnummer: (317) 988-5000
- E-post: matthew.turner@va.gov
Studieorter
-
-
Indiana
-
Indianapolis, Indiana, Förenta staterna, 46202-2884
- Richard L. Roudebush VA Medical Center, Indianapolis, IN
-
Kontakt:
- Matthew J Turner, MD
- Telefonnummer: 317-988-5000
- E-post: matthew.turner@va.gov
-
Huvudutredare:
- Matthew J Turner, MD
-
-
Ohio
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Dayton, Ohio, Förenta staterna, 45428
- Dayton VA Medical Center, Dayton, OH
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Kontakt:
- Jeffrey B Travers, MD
- E-post: jeffrey.travers@va.gov
-
Kontakt:
- Craig A Rohan, MD
- E-post: craig.rohan@va.gov
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Adult Males and Females age 60 and older with 5 or more AKs on each forearm
- Skin type fair-Fitzpatrick I-II
- Able to comprehend procedures and risks
Exclusion Criteria:
- More than 10 AKs on an extremity, or AKs that are large (2-3+)
- Medical history of Diabetes
- Coagulopathy or easy bleeding
- History of poor wound healing or scarring
- Large tattoos that can interfere with study
- Other serious health issues and other skin diseases that could interfere with the study
- Recent (within 1 year) field therapies such as Efudex cream or PDT to forearms
- Planning to leave region in next 4 years
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Microneedling - Male
Forearm treatment with microneedling
|
Microneedling- a mechanical tool that makes tiny holes in a superficial part of the skin
|
|
Experimentell: Microneedling - Female
Forearm treatment with microneedling
|
Microneedling- a mechanical tool that makes tiny holes in a superficial part of the skin
|
|
Experimentell: Trichloroacetic acid peel - Male
Forearm treatment with trichloroacetic acid peel
|
Trichloroacetic acid peel that removes a superficial part of the skin
|
|
Experimentell: Trichloroacetic acid peel - Female
Forearm treatment with trichloroacetic acid peel
|
Trichloroacetic acid peel that removes a superficial part of the skin
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change From Baseline in the Number of Actinic Keratosis due to treatment.
Tidsram: up to 4 years
|
Investigator will assess the number of actinic keratosis on both forearms
|
up to 4 years
|
|
Change From Baseline in the Number Non-Melanoma Skin Cancers due to treatment.
Tidsram: up to 4 years
|
Investigator will assess the number of nonmelanoma skin cancers on both forearms.
|
up to 4 years
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Matthew J Turner, MD, Richard L. Roudebush VA Medical Center, Indianapolis, IN
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ONCE-003-25S
- RD001084 (Annat bidrag/finansieringsnummer: U.S. Veterans Administration)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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