Trial Outcomes & Findings for Effect of Dermal Rejuvenation on the UVB Response of Geriatric Skin (NCT NCT02090894)

NCT ID: NCT02090894

Last Updated: 2018-10-11

Results Overview

Number of double positive cells per 1000 total basal layer keratinocytes

Recruitment status

COMPLETED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

untreated and LaserGenesis treated, three months after treatment, 24 hours after 350 J/m2 of UVB

Results posted on

2018-10-11

Participant Flow

Participant milestones

Participant milestones
Measure	UV Light 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
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Dermal Rejuvenation on the UVB Response of Geriatric Skin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LaserGenesis Treatment n=11 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: untreated and LaserGenesis treated, three months after treatment, 24 hours after 350 J/m2 of UVB

Population: untreated and laser treated biopsies were taken from each subject

Number of double positive cells per 1000 total basal layer keratinocytes

Outcome measures

Outcome measures
Measure	LaserGenesis Treatment n=11 Participants 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
Difference in Basal Layer Keratinocytes Positive for Both Ki67 and Thymine Dimers Untreated skin	21.5 positive cells/1000 basal layer cells Standard Deviation 16.3
Difference in Basal Layer Keratinocytes Positive for Both Ki67 and Thymine Dimers Laser-treated skin	14.7 positive cells/1000 basal layer cells Standard Deviation 13.4

SECONDARY outcome

Timeframe: untreated and LaserGenesis treated, three months after treatment

Population: untreated and laser treated biopsies were taken from each subject

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.

Outcome measures

Outcome measures
Measure	LaserGenesis Treatment n=11 Participants 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
Relative Level of IGF-1 mRNA in the Skin Untreated skin	70.5 relative mRNA Standard Error 22.1
Relative Level of IGF-1 mRNA in the Skin Laser-treated skin	115.1 relative mRNA Standard Error 43.9

Adverse Events

LaserGenesis Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ally-Khan Somani

Indiana University School of Medicine

Phone: 317-944-7744

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place