Clinical trial · Interventional
Therapeutic Induction of Dermal Remodeling in Veterans to Prevent Actinic Neoplasia Caused by Chronic Environmental Exposure to Ultraviolet Radiation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
| Nonmelanoma Skin Cancer | Skin Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microneedling | Other | — | UNRESOLVED |
| Trichloroacetic acid peel | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Microneedling - Male
- description
- Forearm treatment with microneedling
- interventionNames
- Other: Microneedling
- type
- EXPERIMENTAL
- label
- Microneedling - Female
- description
- Forearm treatment with microneedling
- interventionNames
- Other: Microneedling
- type
- EXPERIMENTAL
- label
- Trichloroacetic acid peel - Male
- description
- Forearm treatment with trichloroacetic acid peel
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available