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

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ClinicalTrials.gov Identifier: NCT02090894
Recruitment Status : Completed
First Posted : March 18, 2014
Results First Posted : July 2, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Ally-Khan Somani, Indiana University

Brief 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.

Condition or disease Intervention/treatment Phase
Pre-cancerous Geriatric Skin Device: UV Light (Laser Genesis) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Dermal Rejuvenation on the UVB Response of Geriatric Skin
Study Start Date : March 2011
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: UV Light Device: UV Light (Laser Genesis)



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 99 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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?

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090894


Locations
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United States, Indiana
Indiana University Department of Dermatology
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
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Responsible Party: Ally-Khan Somani, M.D., Ph.D., Indiana University
ClinicalTrials.gov Identifier: NCT02090894    
Other Study ID Numbers: 1105005442
First Posted: March 18, 2014    Key Record Dates
Results First Posted: July 2, 2018
Last Update Posted: October 11, 2018
Last Verified: May 2018