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| Name | Class |
|---|---|
| University of Miami | OTHER |
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There will be five subjects over the age of 65, each with at least one ecchymotic lesion on each arm measuring at least one cm, and five control subjects under the age of 35, both who will be randomized to undergo 4 Sciton Broad Band Light (BBL) treatments on either their left or right arm one week apart. Subjects will fill out questionnaires, have pictures of their lower arms taken, and will be graded and measured by evaluators regarding the number and size of their ecchymoses as well as side effects such as blistering, pain, erythema, and swelling. One day after their 4th treatment on each arm, subjects will have biopsies done to be analyzed for changes in histology and gene expression. The subjects will follow up 1 month after their last treatments for final pictures of their lower arms and evaluations.
This will be a single center, prospective, split-arm clinical study in which subjects will be randomized to which arm will be treated with Sciton's broad band light (BBL) treatment. All subjects will have their arms shaved prior to the procedure and cleaned thoroughly with alcohol. After the procedure a zinc-based sunscreen will be applied to both arms.
Before each of the four treatments, and 1 month after the last treatment, the subjects' number and square area of ecchymoses will be measured by an evaluator and photographs will be taken. Side effects will be measured the same day as the treatment as well as 1 day, 2 days, and 7 days after the first treatment.
A final assessment will be done by taking two skin biopsies from the subjects with senile purpura, one on treated skin and one on untreated skin, and one skin biopsy on untreated skin in the younger controls. The skin specimens will be bisected and one half will be submerged immediately in 10x volumes of formalin while the other half of the biopsy will be submerged immediately in 10x volumes of RNAlater (Thermo Fisher Scientific, Waltham, MA). These specimens will then be coded and sent to blinded evaluators that will embed half in paraffin sections and then stain them with hematoxylin and eosin (H&E), von Giesen and or periodic acid-Schiff (PAS).
Epidermal thickness will be measured on H&E-stained sections using the AxioVision image analysis software (Carl Zeiss Microimaging, Thornwood, NY). The epithelial thickness may vary from area to area within the biopsy. The thickness of the epithelium in µm will be measured at 6 points in each biopsy and averaged. Von Giesen-stained sections will be examined for elastosis, and PAS-stained sections will be examined for collagen.
Total RNA will be extracted using TRIzol Reagent (Thermo Fisher Scientific, Waltham, MA) and the RNeasy mini kit (Qiagen, Valencia, CA). RNA will be reverse transcribed using qScript™ cDNA Synthesis Kit (QuantaBio, Beverly, MA). Real-time qPCR reactions will be carried out using PerfeCTa SYBR® Green SuperMix (QuantaBio, Beverly, MA) in triplicates. Gene expression levels will be normalized to a housekeeping gene, and analyzed using t test of means and SEM. Potential analysis include various biomarkers for dermal remodeling (e.g., collagen type I, elastin), epidermal differentiation (e.g., keratin 1, filaggrin), and vascular changes (e.g., endothelin, Ang).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BBL Left | Experimental | Left arm selected to be treated with BBL, right arm not treated |
|
| BBL Right | Experimental | Right arm selected to be treated with BBL, left arm not treated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Broad Band Light (BBL) | Device | Sciton's BBL treatment using a new protocol that utilizes a 590nm, 560nm, and skintyte filter |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change From Baseline to 30 Days After the Last Treatment in the Number of Senile Purpura Lesions | The number of purpuric lesions 30 days after the last treatment will be subtracted from the number of purpuric lesions at baseline | 51 days (Treatments done every 7 days starting on Day 0 and ending on Day 21, then the final outcome was measured 30 days after the last treatment) |
| The Change in Total Square Size of Purpuric Lesions From Baseline to 30 Days After the Last Treatment | The size of the purpuric lesions will be measured by multiplying the height by the width in cm of each lesion and totaling the total cm2 area for each lesion on each arm. Then the total square area 30 days after the last treatment will be subtracted from the total square area at baseline. | 51 Days (30 days after the final treatment at Day 21) |
| Measure | Description | Time Frame |
|---|---|---|
| Epidermal Thickness 1 Day After the Fourth BBL Treatment | Measurement of epidermal thickness in um as measured by H&E stained sections using the AxionVision image analysis software based on slides from biopsies taken from the subjects 1 days after their last treatment. | 22 days (1 day after final treatment at day 21) |
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Inclusion Criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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| Name | Affiliation | Role |
|---|---|---|
| Robyn Siperstein, MD | Siperstein Dermatology/ University of Miami | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siperstein Dermatology Group | Boynton Beach | Florida | 33472 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29336034 | Background | Faucz LL, Will SE, Rodrigues CJ, Hesse H, Moraes AC, Maria DA. Quantitative evaluation of collagen and elastic fibers after intense pulsed light treatment of mouse skin. Lasers Surg Med. 2018 Jan 16. doi: 10.1002/lsm.22782. Online ahead of print. | |
| 10971556 | Background | Bitter PH. Noninvasive rejuvenation of photodamaged skin using serial, full-face intense pulsed light treatments. Dermatol Surg. 2000 Sep;26(9):835-42; discussion 843. doi: 10.1046/j.1524-4725.2000.00085.x. |
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5 subjects with senile pupura were enrolled in the trial and analyzed. An additional 5 subjects without senile purpura were also enrolled as a control for some secondary measures.
| ID | Title | Description |
|---|---|---|
| FG000 | BBL Treatment | One arm was randomly selected to receive treatment with Sciton's BBL according to a protocol with multiple passes with different filters and settings. |
| FG001 | No Treatment | One arm was not treated |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The overall number of units analyzed represent the arms of participants with senile purpura.
| ID | Title | Description |
|---|---|---|
| BG000 | BBL Treatment | One arm was randomly selected to receive treatment with Sciton's BBL with multiple passes using a new protocol with varying filters and settings. |
| BG001 | No Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Change From Baseline to 30 Days After the Last Treatment in the Number of Senile Purpura Lesions | The number of purpuric lesions 30 days after the last treatment will be subtracted from the number of purpuric lesions at baseline | This outcome measure was only assessed in those with purpuric lesions | Posted | Median | Full Range | number of purpuric lesions | 51 days (Treatments done every 7 days starting on Day 0 and ending on Day 21, then the final outcome was measured 30 days after the last treatment) |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BBL Treatment | One arm was randomly selected to receive treatment with Sciton's BBL |
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Small pilot study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| founder/physician | Siperstein Dermatology Group | 5613647774 | info@sipderm.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 27, 2018 | Dec 13, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D004438 | Ecchymosis |
| D021921 | Aortic Stenosis, Supravalvular |
| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006470 | Hemorrhage |
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| 21242389 | Background | McKenzie NE, Saboda K, Duckett LD, Goldman R, Hu C, Curiel-Lewandrowski CN. Development of a photographic scale for consistency and guidance in dermatologic assessment of forearm sun damage. Arch Dermatol. 2011 Jan;147(1):31-6. doi: 10.1001/archdermatol.2010.392. |
| 19289681 | Background | DeFatta RJ, Krishna S, Williams EF 3rd. Pulsed-dye laser for treating ecchymoses after facial cosmetic procedures. Arch Facial Plast Surg. 2009 Mar-Apr;11(2):99-103. doi: 10.1001/archfacial.2008.538. |
| 28858925 | Background | Brauer JA, Farhadian JA, Bernstein LJ, Bae YS, Geronemus RG. Pulsed Dye Laser at Subpurpuric Settings for the Treatment of Pulsed Dye Laser-Induced Ecchymoses in Patients With Port-Wine Stains. Dermatol Surg. 2018 Feb;44(2):220-226. doi: 10.1097/DSS.0000000000001255. |
| 22931923 | Background | Chang AL, Bitter PH Jr, Qu K, Lin M, Rapicavoli NA, Chang HY. Rejuvenation of gene expression pattern of aged human skin by broadband light treatment: a pilot study. J Invest Dermatol. 2013 Feb;133(2):394-402. doi: 10.1038/jid.2012.287. Epub 2012 Aug 30. |
| 11870785 | Background | Prieto VG, Sadick NS, Lloreta J, Nicholson J, Shea CR. Effects of intense pulsed light on sun-damaged human skin, routine, and ultrastructural analysis. Lasers Surg Med. 2002;30(2):82-5. doi: 10.1002/lsm.10042. |
One arm was not treated
| BG002 | Total | Total of all reporting groups |
| arms |
|
| Participants |
| Participants |
|
|
| Sex: Female, Male | Only the subjects with senile purpura (5 of 10) were analyzed for measurements of senile purpura | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Region of Enrollment | Number | participants | Participants |
|
|
| Square Area of Purpuric Lesions | Measurement of purpuric lesion size was done by multiplying the width by the height of the lesion in cm and therefore the final measurement is cm2. This was done only in the 10 arms (5 participants) that had senile purpura at baseline. | Measurement of purpuric lesion size was only done in 10 arms (5 participants with senile purpura). The other 5 participants were used as controls for other measures. | Mean | Full Range | cm2 | arms |
|
|
| Number of Purpuric Lesions | The number of individual purpuric lesions were counted | Only 5 participants (10 arms) were analyzed regarding number of purpuric lesions and size of purpuric lesions. The additional 5 younger subjects were used as to compare changes in mrna and skin thickness but could not be used to measure purpuric lesions as they did not have any. | Mean | Full Range | purpuric lesions | arms |
|
|
|
|
| Primary | The Change in Total Square Size of Purpuric Lesions From Baseline to 30 Days After the Last Treatment | The size of the purpuric lesions will be measured by multiplying the height by the width in cm of each lesion and totaling the total cm2 area for each lesion on each arm. Then the total square area 30 days after the last treatment will be subtracted from the total square area at baseline. | This measure was only assessed in those with purpuric lesions | Posted | Mean | Full Range | cm2 | 51 Days (30 days after the final treatment at Day 21) |
|
|
|
| Secondary | Epidermal Thickness 1 Day After the Fourth BBL Treatment | Measurement of epidermal thickness in um as measured by H&E stained sections using the AxionVision image analysis software based on slides from biopsies taken from the subjects 1 days after their last treatment. | Data collected for those participants with senile purpura for both interventions, data collected for those participants without for only the control no treatment arm | Posted | Mean | Full Range | um | 22 days (1 day after final treatment at day 21) |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | No Treatment | One arm was not treated | 0 | 10 | 0 | 10 | 0 | 10 |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |