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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Matthew J Turner, MD
- Telefonnummer: (317) 988-5000
- E-post: matthew.turner@va.gov
Studiesteder
-
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Indiana
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Indianapolis, Indiana, Forente stater, 46202-2884
- Richard L. Roudebush VA Medical Center, Indianapolis, IN
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Ta kontakt med:
- Matthew J Turner, MD
- Telefonnummer: 317-988-5000
- E-post: matthew.turner@va.gov
-
Hovedetterforsker:
- Matthew J Turner, MD
-
-
Ohio
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Dayton, Ohio, Forente stater, 45428
- Dayton VA Medical Center, Dayton, OH
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Ta kontakt med:
- Jeffrey B Travers, MD
- E-post: jeffrey.travers@va.gov
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Ta kontakt med:
- Craig A Rohan, MD
- E-post: craig.rohan@va.gov
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Microneedling - Male
Forearm treatment with microneedling
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Microneedling- a mechanical tool that makes tiny holes in a superficial part of the skin
|
|
Eksperimentell: Microneedling - Female
Forearm treatment with microneedling
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Microneedling- a mechanical tool that makes tiny holes in a superficial part of the skin
|
|
Eksperimentell: Trichloroacetic acid peel - Male
Forearm treatment with trichloroacetic acid peel
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Trichloroacetic acid peel that removes a superficial part of the skin
|
|
Eksperimentell: Trichloroacetic acid peel - Female
Forearm treatment with trichloroacetic acid peel
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Trichloroacetic acid peel that removes a superficial part of the skin
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in the Number of Actinic Keratosis due to treatment.
Tidsramme: up to 4 years
|
Investigator will assess the number of actinic keratosis on both forearms
|
up to 4 years
|
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Change From Baseline in the Number Non-Melanoma Skin Cancers due to treatment.
Tidsramme: up to 4 years
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Investigator will assess the number of nonmelanoma skin cancers on both forearms.
|
up to 4 years
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Matthew J Turner, MD, Richard L. Roudebush VA Medical Center, Indianapolis, IN
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ONCE-003-25S
- RD001084 (Annet stipend/finansieringsnummer: U.S. Veterans Administration)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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