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Completed

NCT Number: NCT03243981

Infrared and Broadband Light for Skin Aging

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.

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Key information

Conditions

Age range

55 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Redwood City, California, 94063, United States

About this study

Studies in model organisms suggest that aged cells can be functionally rejuvenated, but whether this concept applies to human skin is unclear. Recently, we applied 3'-end sequencing for expression quantification ("3-seq") to discover the gene expression program associated with human photoaging and intrinsic skin aging (collectively termed "skin aging"), and the impact of broadband light (BBL) treatment. We found significant changes in 2,265 coding and noncoding RNAs, of which 1,293 that became "rejuvenated" after BBL treatment, whereby they became more similar to their expression level in youthful skin. Rejuvenated genes (RGs) included several known key regulators of organismal longevity and their proximal long noncoding RNAs. Hence, BBL treatment can restore gene expression pattern of photo-aged and intrinsically aged human skin to resemble young skin.

However, the duration of these effects and the potential to augment these effects through increases in particular wavelengths of light have not been explored. The Sciton SkinTyte (800-1800nm) is the ideal technology to examine these questions, since this device has been used in the clinical setting to reduce cheek and submental laxity (Gold, 2010). It incorporates the broadband light technology with an emphasis on 590 nm filter to achieve these clinical results.

This study will be conducted in accord with Declaration of Helsinki principles. After Institutional Review Board approval and informed consent is obtained, six female participants over the age of 55 years will undergo BBLST treatments to the left forearm. Inclusion criteria included Fitzpatrick skin type II or III, and a global assessment of forearm skin aging consistent with moderate or severe forearm skin aging (modified validated instrument from McKenzie et al., 2011) for treated participants. Treatments will be performed on the Sciton Joule Platform using BBL in Skintyte mode with 590ST filter. On a separate part of the arm that is clearly marked, Skintyte alone will be applied. Untreated areas will also be marked. All markings will be photographed. The same investigator will perform the treatments at 4-week intervals for a total of 3 treatments. At each treatment session, two or more passes were performed. Four weeks after the third BBL treatment, 4 mm skin biopsies will performed by Keys punch technique from the BBLST treated, ST treated and adjacent untreated skin. These specimens will be bisected and placed into either RNAlater (Ambion Cat# AM7022) or formalin solution for with H&E, von Giesen or PAS staining.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. 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

Exclusion criteria

  • 1. 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)

Treatment and study plan

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).

Primary outcomes

  1. Number of Genes With Significant Change in Gene Transcription

    Time frame: 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.

Secondary outcomes

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

    Time frame: Baseline, day 84

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

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

    Time frame: Baseline, day 84

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

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

    Time frame: Baseline, day 84

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

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

    Time frame: Baseline, day 84

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

  5. Change From Baseline in Cutometry as a Measure of Skin Rejuvenation

    Time frame: Baseline, day 84

    Elasticity of skin assessment with cutometric probe.

  6. Change From Baseline in Transepidermal Water Loss as a Measure of Skin Rejuvenation

    Time frame: Baseline, day 84

    Transepidermal water loss assessment with VapoMeter.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Sciton

Registry information

Official study title

Augmentation of Skin Aging Reversal By Broadband Light With Skin Tightening Properties Via Gene Expression Analysis

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 9, 2017
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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