Effect of Dermal Rejuvenation on the UVB Response of Geriatric Skin (Laser Genesis)

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.

Study Overview

• Status: Completed
• Conditions: Pre-cancerous Geriatric Skin
• Intervention / Treatment: Device: UV Light (Laser Genesis)

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 99 years (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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?

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: UV Light	Device: UV Light (Laser Genesis)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Basal Layer Keratinocytes Positive for Both Ki67 and Thymine Dimers	Number of double positive cells per 1000 total basal layer keratinocytes	untreated and LaserGenesis treated, three months after treatment, 24 hours after 350 J/m2 of UVB

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative Level of IGF-1 mRNA in the Skin	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.	untreated and LaserGenesis treated, three months after treatment

Collaborators and Investigators

• Sponsor: Indiana University

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ACTUAL): December 1, 2016
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: January 28, 2014
• First Submitted That Met QC Criteria: March 17, 2014
• First Posted (ESTIMATE): March 18, 2014

Study Record Updates

• Last Update Posted (ACTUAL): October 11, 2018
• Last Update Submitted That Met QC Criteria: September 14, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 1105005442