Effect of Dermal Rejuvenation on the UVB Response of Geriatric Skin

NCT ID: NCT02090894

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2016-12-31

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.

Conditions

Pre-cancerous Geriatric Skin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

UV Light

Group Type: EXPERIMENTAL

UV Light (Laser Genesis)

Intervention Type: DEVICE

Interventions

UV Light (Laser Genesis)

Intervention Type: DEVICE

Eligibility 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.

• 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?

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Ally-Khan Somani

M.D., Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Indiana University Department of Dermatology

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

1105005442

Identifier Type: -

Identifier Source: org_study_id