Infrared and Broadband Light for Skin Aging

NCT03243981 | Completed Results DMC FDA Device

• 1 other identifier: IRB 37776
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

In this exploratory study, we hope to learn if treatment of broadband light with infrared light can alter the molecular pathways associated with aging. Secondary exploratory objective is to see if there are any visible effects of this light treatment on human skin.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• Number of Genes With Significant Change in Gene Transcription

  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.

  16 weeks

Secondary Outcomes (6)

• Change From Baseline in Fine Wrinkling Score as a Measure of Skin Rejuvenation

  Baseline, day 84

• Change From Baseline in Coarse Wrinkling Score as a Measure of Skin Rejuvenation

  Baseline, day 84

• Change From Baseline in Sagging Score as a Measure of Skin Rejuvenation

  Baseline, day 84

• Change From Baseline in Physician Global Assessment as a Measure of Skin Rejuvenation

  Baseline, day 84

• Change From Baseline in Cutometry as a Measure of Skin Rejuvenation

  Baseline, day 84

Study Arms (1)

Open label study-- single arm

EXPERIMENTAL

All patients will receive Skintyte treatment as well as Skintyte plus broadband light

Device: Sciton SkinTyte (800-1800 nm) with Broadband Light Technology

Interventions

Sciton SkinTyte (800-1800 nm) with Broadband Light Technology DEVICE

This device has been used in the clinical setting to reduce cheek and submental laxity. SkinTyte delivers sequentially pulsed light (800-1200 nm, with a filter enabling focus on 590 nm) and broadband light (which can be turned on or off).

Open label study-- single arm

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Female 2. Age 55 years or older (total 6) 3. Fitzpatrick skin type 2-3 4. Photo-aging at least moderate on the extensor forearms

You may not qualify if:

• \. Unable to understand and sign informed consent form 2. Unable to comply with study procedures 3. Pregnant or lactating 4. Prior treatment to forearms including topical retinoid, laser treatment, photodynamic treatment, prescription topical agents x 1 month 5. Active skin conditions that precluding treatment including zoster, blistering skin disease, psoriasis, atopic dermatitis, abnormal scarring, skin cancer in the area of study treatment 6. Currently on hormone based therapy (both systemic and topical)

Sponsors & Collaborators

• Stanford University: lead
• Sciton: collaborator

Study Sites (1)

Stanford University

Redwood City, California, 94063, United States

Location

Limitations and Caveats

The study did not meet its planned sample size.

Results Point of Contact

• Title: Anne Lynn Chang, MD
• Organization: Stanford University

alschang@stanford.edu

650-723-6316

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Dermatology

Model Details: Application of Skintyte and/or broadband light to skin

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: August 9, 2017
• Study Start: November 20, 2016
• Primary Completion: June 20, 2017
• Study Completion: June 20, 2017
• Last Updated: October 1, 2019
• Results First Posted: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)