Clinical trial NCT02090894: Effect of Dermal Rejuvenation on the UVB Response of Geriatric Skin
Official title: Effect of Dermal Rejuvenation on the UVB Response of Geriatric Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-cancerous Geriatric Skin
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 11
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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.

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?

Primary outcomes:
measure: Difference in Basal Layer Keratinocytes Positive for Both Ki67 and Thymine Dimers
timeFrame: untreated and LaserGenesis treated, three months after treatment, 24 hours after 350 J/m2 of UVB
Secondary outcomes:
measure: Relative Level of IGF-1 mRNA in the Skin
timeFrame: untreated and LaserGenesis treated, three months after treatment
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Department of Dermatology
state: Indiana
Study officials:
References: