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

• Sponsor: Indiana University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02090894
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arm: 1
• Duration (Months): 69.1
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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)	N/A

Study Design

• Study Type: Interventional
• 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: Mar 1, 2011
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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?

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Department of Dermatology	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• Indiana University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ally-Khan Somani, M.D., Ph.D., Indiana University
• ClinicalTrials.gov Identifier: NCT02090894
• Other Study ID Numbers: 1105005442
• First Posted: Mar 18, 2014
• Last Update Posted: Oct 11, 2018
• Last Verified: May 1, 2018

Study Results

Participant Flow

Arm/Group Title	UV Light
Arm/Group Description	UV Light (Laser Genesis). 1064 nm laser at a fluence of 13-16 J/cm2 and a pulse width of 0.3 ms and a 5 mm spot size
Period Title: Overall Study
STARTED	11
COMPLETED	11
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	LaserGenesis Treatment
Arm/Group Description	1064 nm laser at a fluence of 13-16 J/cm2 and a pulse width of 0.3 ms and a 5 mm spot size
Overall Participants	11
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	0 0%
>=65 years	11 100%
Sex: Female, Male (Count of Participants)
Female	7 63.6%
Male	4 36.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	11 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	11 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

untreated and laser treated biopsies were taken from each subject

Arm/Group Title	LaserGenesis Treatment
Arm/Group Description	1064 nm laser at a fluence of 13-16 J/cm2 and a pulse width of 0.3 ms and a 5 mm spot size
Measure Participants	11
Untreated skin	21.5 (16.3)
Laser-treated skin	14.7 (13.4)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

untreated and laser treated biopsies were taken from each subject

Arm/Group Title	LaserGenesis Treatment
Arm/Group Description	1064 nm laser at a fluence of 13-16 J/cm2 and a pulse width of 0.3 ms and a 5 mm spot size
Measure Participants	11
Untreated skin	70.5 (22.1)
Laser-treated skin	115.1 (43.9)

Adverse Events

Time Frame	3 months
Arm/Group Title	LaserGenesis Treatment
Arm/Group Description	1064 nm laser at a fluence of 13-16 J/cm2 and a pulse width of 0.3 ms with a 5 mm spot size
All Cause Mortality
	LaserGenesis Treatment
	Affected / at Risk (%)	# Events
Total	0/11 (0%)
Serious Adverse Events
	LaserGenesis Treatment
	Affected / at Risk (%)	# Events
Total	0/11 (0%)
Other (Not Including Serious) Adverse Events
	LaserGenesis Treatment
	Affected / at Risk (%)	# Events
Total	0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.