Completed

NCT Number: NCT02090894

Effect of Dermal Rejuvenation on the UVB Response of Geriatric Skin

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.

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Key information

Conditions

Pre-cancerous Geriatric Skin

Age range

65 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Department of Dermatology

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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?

Treatment and study plan

UV Light (Laser Genesis)

Device

Primary outcomes

Difference in Basal Layer Keratinocytes Positive for Both Ki67 and Thymine Dimers

Time frame: untreated and LaserGenesis treated, three months after treatment, 24 hours after 350 J/m2 of UVB

Number of double positive cells per 1000 total basal layer keratinocytes

Secondary outcomes

Relative Level of IGF-1 mRNA in the Skin

Time frame: untreated and LaserGenesis treated, three months after treatment

IGF-1 mRNA per 100,000 beta-2 microglobulin mRNA. Beta-2 microglobulin mRNA was used as a reference gene for this assessment and that the data represent number of copies IGF-1/100,000 copies b2-microglobulin.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Acronym: Laser Genesis

Important dates

Study start: 2011
Primary completion: 2016
Study completion: 2016
First posted: Mar 18, 2014
Registry last updated: Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.