Overview

This trial is active, not recruiting.

Condition pre-cancerous geriatric skin
Treatment uv light (laser genesis)
Sponsor Indiana University
Start date March 2011
End date December 2016
Trial size 24 participants
Trial identifier NCT02090894, 1105005442

Summary

The objective of this study is to examine the ability of dermal rejuvenation therapies to protect geriatric skin from ultraviolet light (UVB)-induced carcinogenesis. Skin cancers (including basal cell carcinoma and squamous cell carcinoma) are the most common types of malignancy and are related to UVB exposure in sunlight. UVB-irradiation of skin causes specific DNA damage to keratinocytes that can lead to cancer-causing mutations if they are allowed to persist in proliferating cells. Moreover, the incidence of skin cancers is much greater in elderly over younger individuals. The objective of the present study is to build upon our previous data and test the effect of a non ablative Nd:YAG laser (LaserGenesis) of a localized area of skin on dermal IGF-1 production and UVB-mediated keratinocyte effects. Treatment of skin using a non ablative high-peak power microsecond pulsed 1064 nm Nd:YAG laser (Cutera's LaserGenesisTM laser) leads to papillary dermal heating. The laser targets the microvasculature and stimulates collagen production while protecting the epidermis. Generally, Laser Genesis is used clinically to improve irregularities in the contour, texture, and color of the skin. Laser Genesis is also used to help treat photoaging by increasing collagen formation, suggesting that it stimulates fibroblast activity and thus possibly increases levels of protective IGF-1.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
uv light (laser genesis)

Primary Outcomes

Measure
Measure the response of ultraviolet light on geriatric skin
time frame: 3 months

Eligibility Criteria

Male or female participants from 65 years up to 99 years old.

Inclusion Criteria: - Only subjects older than 65 years will be enrolled. - Subject's skin type must be "Fair", Fitzpatrick type I or II. Exclusion Criteria: - Subjects who have underlying diseases that could affect wound healing (eg, diabetes mellitus) - on medications that are known photosensitizers, - or have a history of abnormal scarring (eg, keloids) will be excluded. Subjects will be asked the screening questions below as part of the inclusion/exclusion criteria - How old are you? - Do you regularly use tanning beds? - Are you being treated with light therapy? - Have you had any diseases that got worse when you went in the sun? - Are you taking any medications that warn you to stay out of the sun? - Have you ever had a reaction to medications that were applied to your skin? - When cuts or wounds on your skin heal, are the scars abnormally large or take a long time to heal? - Do you have diabetes mellitus or have you ever had high blood sugar?

Additional Information

Official title Effect of Dermal Rejuvenation on the UVB Response of Geriatric Skin
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Indiana University.