Aging
Conditions
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.
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.
Interventions
DEVICESciton 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).
Sponsors
Sciton
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Application of Skintyte and/or broadband light to skin
Eligibility
Sex/Gender
FEMALE
Age
55 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Genes With Significant Change in Gene Transcription | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Coarse Wrinkling Score as a Measure of Skin Rejuvenation | Baseline, day 84 | Wrinkling was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more wrinkling. |
| Change From Baseline in Sagging Score as a Measure of Skin Rejuvenation | Baseline, day 84 | Sagging was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more sagging. |
| Change From Baseline in Fine Wrinkling Score as a Measure of Skin Rejuvenation | Baseline, day 84 | Wrinkling was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more wrinkling. |
| Change From Baseline in Cutometry as a Measure of Skin Rejuvenation | Baseline, day 84 | Elasticity of skin assessment with cutometric probe. |
| Change From Baseline in Transepidermal Water Loss as a Measure of Skin Rejuvenation | Baseline, day 84 | Transepidermal water loss assessment with VapoMeter. |
| Change From Baseline in Physician Global Assessment as a Measure of Skin Rejuvenation | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Skintyte All patients will receive Skintyte treatment as well as Skintyte plus broadband light using the Sciton SkinTyte device. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Skintyte |
|---|---|
| Age, Continuous | 67.6 years STANDARD_DEVIATION 6.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 5 |
Outcome results
Primary
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.
Time frame: 16 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BBL + SPL590 vs Untreated | Number of Genes With Significant Change in Gene Transcription | 188 genes |
| SPL800 (SkinTite 2) vs Untreated | Number of Genes With Significant Change in Gene Transcription | 45 genes |
Secondary
Change From Baseline in Coarse Wrinkling Score as a Measure of Skin Rejuvenation
Wrinkling was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more wrinkling.
Time frame: Baseline, day 84
Population: Participants that had assessments at baseline and day 84 are included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BBL + SPL590 vs Untreated | Change From Baseline in Coarse Wrinkling Score as a Measure of Skin Rejuvenation | Baseline | 5.0 score on a scale | Standard Deviation 3.65 |
| BBL + SPL590 vs Untreated | 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 |
| SPL800 (SkinTite 2) vs Untreated | Change From Baseline in Coarse Wrinkling Score as a Measure of Skin Rejuvenation | Baseline | 6.0 score on a scale | Standard Deviation 1.83 |
| SPL800 (SkinTite 2) vs Untreated | Change From Baseline in Coarse Wrinkling Score as a Measure of Skin Rejuvenation | Day 84 | 2.5 score on a scale | Standard Deviation 1.73 |
Secondary
Change From Baseline in Cutometry as a Measure of Skin Rejuvenation
Elasticity of skin assessment with cutometric probe.
Time frame: Baseline, day 84
Population: Data were not collected for this outcome
Secondary
Change From Baseline in Fine Wrinkling Score as a Measure of Skin Rejuvenation
Wrinkling was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more wrinkling.
Time frame: Baseline, day 84
Population: Participants that had assessments at baseline and day 84 are included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BBL + SPL590 vs Untreated | Change From Baseline in Fine Wrinkling Score as a Measure of Skin Rejuvenation | Baseline | 7.8 score on a scale | Standard Deviation 1.89 |
| BBL + SPL590 vs Untreated | 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 |
| SPL800 (SkinTite 2) vs Untreated | Change From Baseline in Fine Wrinkling Score as a Measure of Skin Rejuvenation | Baseline | 7.5 score on a scale | Standard Deviation 3.7 |
| SPL800 (SkinTite 2) vs Untreated | Change From Baseline in Fine Wrinkling Score as a Measure of Skin Rejuvenation | Day 84 | 5.3 score on a scale | Standard Deviation 3.2 |
Secondary
Change From Baseline in Physician Global Assessment as a Measure of Skin Rejuvenation
Physician global assessment was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more severe skin aging.
Time frame: Baseline, day 84
Population: Participants that had assessments at baseline and day 84 are included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BBL + SPL590 vs Untreated | Change From Baseline in Physician Global Assessment as a Measure of Skin Rejuvenation | Baseline | 8.3 score on a scale | Standard Deviation 0.96 |
| BBL + SPL590 vs Untreated | 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 |
| SPL800 (SkinTite 2) vs Untreated | Change From Baseline in Physician Global Assessment as a Measure of Skin Rejuvenation | Baseline | 8.3 score on a scale | Standard Deviation 1.5 |
| SPL800 (SkinTite 2) vs Untreated | Change From Baseline in Physician Global Assessment as a Measure of Skin Rejuvenation | Day 84 | 6.0 score on a scale | Standard Deviation 1.83 |
Secondary
Change From Baseline in Sagging Score as a Measure of Skin Rejuvenation
Sagging was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more sagging.
Time frame: Baseline, day 84
Population: Participants that had assessments at baseline and day 84 are included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BBL + SPL590 vs Untreated | Change From Baseline in Sagging Score as a Measure of Skin Rejuvenation | Baseline | 7.0 score on a scale | Standard Deviation 1.63 |
| BBL + SPL590 vs Untreated | Change From Baseline in Sagging Score as a Measure of Skin Rejuvenation | Day 84 | 3.5 score on a scale | Standard Deviation 1.73 |
| SPL800 (SkinTite 2) vs Untreated | Change From Baseline in Sagging Score as a Measure of Skin Rejuvenation | Baseline | 7.5 score on a scale | Standard Deviation 1.91 |
| SPL800 (SkinTite 2) vs Untreated | Change From Baseline in Sagging Score as a Measure of Skin Rejuvenation | Day 84 | 4.3 score on a scale | Standard Deviation 2.06 |
Secondary
Change From Baseline in Transepidermal Water Loss as a Measure of Skin Rejuvenation
Transepidermal water loss assessment with VapoMeter.
Time frame: Baseline, day 84
Population: Data were not collected for this outcome