Trial Outcomes & Findings for Infrared and Broadband Light for Skin Aging (NCT NCT03243981)

Results Overview

The endpoint consisted of clinical inspection of biopsies of untreated skin and skin after three treatments. Genes were considered altered if a statistically significant change in transcription of an individual gene was observed between the treated and untreated skin (significance was set at p\<0.01, adjusted for false discovery rate). The values in the table represent the total number of recorded genes with significant change.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

16 weeks

Results posted on

2019-10-01

Participant Flow

Participant milestones

Participant milestones
Measure	Skintyte All patients will receive Skintyte treatment as well as Skintyte plus broadband light using the Sciton SkinTyte device.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Infrared and Broadband Light for Skin Aging

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Skintyte n=5 Participants All patients will receive Skintyte treatment as well as Skintyte plus broadband light using the Sciton SkinTyte device.
Age, Continuous	67.6 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	5 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

PRIMARY outcome

Timeframe: 16 weeks

The endpoint consisted of clinical inspection of biopsies of untreated skin and skin after three treatments. Genes were considered altered if a statistically significant change in transcription of an individual gene was observed between the treated and untreated skin (significance was set at p\<0.01, adjusted for false discovery rate). The values in the table represent the total number of recorded genes with significant change.

Outcome measures

Outcome measures
Measure	BBL + SPL590 vs Untreated n=5 Participants Biopsies were collected from the BBL + SPL590-treated arm (proximal forearm) and the untreated arm (mid-forearm) BBL = broadband light; SPL = sequentially pulsed light	SPL800 (SkinTite 2) vs Untreated n=5 Participants Biopsies were collected fro the SPL800-treated arm (distal forearm) vs untreated arm (mid-forearm) SPL800 = SkinTite 2
Number of Genes With Significant Change in Gene Transcription	188 genes	45 genes

SECONDARY outcome

Timeframe: Baseline, day 84

Population: Participants that had assessments at baseline and day 84 are included in the analysis

Wrinkling was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more wrinkling.

Outcome measures

Outcome measures
Measure	BBL + SPL590 vs Untreated n=4 Participants Biopsies were collected from the BBL + SPL590-treated arm (proximal forearm) and the untreated arm (mid-forearm) BBL = broadband light; SPL = sequentially pulsed light	SPL800 (SkinTite 2) vs Untreated n=4 Participants Biopsies were collected fro the SPL800-treated arm (distal forearm) vs untreated arm (mid-forearm) SPL800 = SkinTite 2
Change From Baseline in Fine Wrinkling Score as a Measure of Skin Rejuvenation Baseline	7.8 score on a scale Standard Deviation 1.89	7.5 score on a scale Standard Deviation 3.70
Change From Baseline in Fine Wrinkling Score as a Measure of Skin Rejuvenation Day 84	5.0 score on a scale Standard Deviation 3.46	5.3 score on a scale Standard Deviation 3.20

SECONDARY outcome

Timeframe: Baseline, day 84

Population: Participants that had assessments at baseline and day 84 are included in the analysis

Wrinkling was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more wrinkling.

Outcome measures

Outcome measures
Measure	BBL + SPL590 vs Untreated n=4 Participants Biopsies were collected from the BBL + SPL590-treated arm (proximal forearm) and the untreated arm (mid-forearm) BBL = broadband light; SPL = sequentially pulsed light	SPL800 (SkinTite 2) vs Untreated n=4 Participants Biopsies were collected fro the SPL800-treated arm (distal forearm) vs untreated arm (mid-forearm) SPL800 = SkinTite 2
Change From Baseline in Coarse Wrinkling Score as a Measure of Skin Rejuvenation Baseline	5.0 score on a scale Standard Deviation 3.65	6.0 score on a scale Standard Deviation 1.83
Change From Baseline in Coarse Wrinkling Score as a Measure of Skin Rejuvenation Day 84	2.3 score on a scale Standard Deviation 2.63	2.5 score on a scale Standard Deviation 1.73

SECONDARY outcome

Timeframe: Baseline, day 84

Population: Participants that had assessments at baseline and day 84 are included in the analysis

Sagging was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more sagging.

Outcome measures

Outcome measures
Measure	BBL + SPL590 vs Untreated n=4 Participants Biopsies were collected from the BBL + SPL590-treated arm (proximal forearm) and the untreated arm (mid-forearm) BBL = broadband light; SPL = sequentially pulsed light	SPL800 (SkinTite 2) vs Untreated n=4 Participants Biopsies were collected fro the SPL800-treated arm (distal forearm) vs untreated arm (mid-forearm) SPL800 = SkinTite 2
Change From Baseline in Sagging Score as a Measure of Skin Rejuvenation Baseline	7.0 score on a scale Standard Deviation 1.63	7.5 score on a scale Standard Deviation 1.91
Change From Baseline in Sagging Score as a Measure of Skin Rejuvenation Day 84	3.5 score on a scale Standard Deviation 1.73	4.3 score on a scale Standard Deviation 2.06

SECONDARY outcome

Timeframe: Baseline, day 84

Population: Participants that had assessments at baseline and day 84 are included in the analysis

Physician global assessment was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more severe skin aging.

Outcome measures

Outcome measures
Measure	BBL + SPL590 vs Untreated n=4 Participants Biopsies were collected from the BBL + SPL590-treated arm (proximal forearm) and the untreated arm (mid-forearm) BBL = broadband light; SPL = sequentially pulsed light	SPL800 (SkinTite 2) vs Untreated n=4 Participants Biopsies were collected fro the SPL800-treated arm (distal forearm) vs untreated arm (mid-forearm) SPL800 = SkinTite 2
Change From Baseline in Physician Global Assessment as a Measure of Skin Rejuvenation Day 84	5.5 score on a scale Standard Deviation 2.08	6.0 score on a scale Standard Deviation 1.83
Change From Baseline in Physician Global Assessment as a Measure of Skin Rejuvenation Baseline	8.3 score on a scale Standard Deviation 0.96	8.3 score on a scale Standard Deviation 1.50

SECONDARY outcome

Timeframe: Baseline, day 84

Population: Data were not collected for this outcome

Elasticity of skin assessment with cutometric probe.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, day 84

Population: Data were not collected for this outcome

Transepidermal water loss assessment with VapoMeter.

Outcome measures

Outcome data not reported

Adverse Events

BBL + SPL590

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SPL800

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Untreated

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

Anne Lynn Chang, MD

Stanford University

Phone: 650-723-6316

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place