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Infrared and Broadband Light for Skin Aging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03243981
Recruitment Status : Completed
First Posted : August 9, 2017
Results First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
Sciton
Information provided by (Responsible Party):
Anne Chang, Stanford University

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.

Condition or disease Intervention/treatment Phase
Aging Device: Sciton SkinTyte (800-1800 nm) with Broadband Light Technology Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Application of Skintyte and/or broadband light to skin
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Augmentation of Skin Aging Reversal By Broadband Light With Skin Tightening Properties Via Gene Expression Analysis
Actual Study Start Date : November 20, 2016
Actual Primary Completion Date : June 20, 2017
Actual Study Completion Date : June 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Open label study-- single arm
All patients will receive Skintyte treatment as well as Skintyte plus broadband light
Device: Sciton SkinTyte (800-1800 nm) with Broadband Light Technology
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 Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03243981


Locations
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United States, California
Stanford University
Redwood City, California, United States, 94063
Sponsors and Collaborators
Stanford University
Sciton
  Study Documents (Full-Text)

Documents provided by Anne Chang, Stanford University:

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Responsible Party: Anne Chang, Associate Professor of Dermatology, Stanford University
ClinicalTrials.gov Identifier: NCT03243981    
Other Study ID Numbers: IRB 37776
First Posted: August 9, 2017    Key Record Dates
Results First Posted: October 1, 2019
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No