Bateman's Purpura, Senile Purpura
Conditions
Keywords
skin atrophy, broad band bight, ecchymosis, collagen, elastin, RNA
Brief summary
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.
Detailed description
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).
Interventions
DEVICEBroad Band Light (BBL)
Sciton's BBL treatment using a new protocol that utilizes a 590nm, 560nm, and skintyte filter
Sponsors
University of Miami
Siperstein Dermatology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged \>22 * In good general health as evidenced by medical history * Ecchymosis greater than 1cm on each arm for the group with senile purpura
Exclusion criteria
An individual who meets any of the following criteria will be excluded from participation in this study: * Subjects with a history of any arm swelling * Subjects with allergies to light * Subjects with auto-immune skin conditions such as lupus, or vitiligo * Subjects using topical retinol within the last 3 months * Subjects with any scheduled laser, light, or surgical procedures on the arm during the study * Subjects unwilling or unable to keep their arms still during digital pictures * Subjects who are pregnant or nursing * Subjects with a history of herpes simplex or zoster on their arms * Subjects with current skin infections, tumors, or dermatitis on the arm * Subjects with allergies to lidocaine * Subjects with a history of keloid formation * Subjects with a history of a bleeding disorder * Subjects with allergies to adhesives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change From Baseline to 30 Days After the Last Treatment in the Number of Senile Purpura 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) | The number of purpuric lesions 30 days after the last treatment will be subtracted from the number of purpuric lesions at baseline |
| The Change in Total Square Size of Purpuric Lesions From Baseline to 30 Days After the Last Treatment | 51 Days (30 days after the final treatment at Day 21) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epidermal Thickness 1 Day After the Fourth BBL Treatment | 22 days (1 day after final treatment at day 21) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 5 |
| No Treatment One arm was not treated | 10 |
| No Treatment One arm was not treated | 5 |
| Total | 30 |
Baseline characteristics
| Characteristic | BBL Treatment | No Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 5 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 10 Participants |
| Number of Purpuric Lesions | 5.8 purpuric lesions | 5 purpuric lesions | 5.4 purpuric lesions |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 10 participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
| Square Area of Purpuric Lesions | 22.8 cm2 | 17.05 cm2 | 19.925 cm2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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
Time frame: 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)
Population: This outcome measure was only assessed in those with purpuric lesions
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BBL Treatment | The Change From Baseline to 30 Days After the Last Treatment in the Number of Senile Purpura Lesions | -3.55 number of purpuric lesions |
| No Treatment | The Change From Baseline to 30 Days After the Last Treatment in the Number of Senile Purpura Lesions | -.35 number of purpuric lesions |
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.
Time frame: 51 Days (30 days after the final treatment at Day 21)
Population: This measure was only assessed in those with purpuric lesions
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BBL Treatment | The Change in Total Square Size of Purpuric Lesions From Baseline to 30 Days After the Last Treatment | -4.8 cm2 |
| No Treatment | The Change in Total Square Size of Purpuric Lesions From Baseline to 30 Days After the Last Treatment | 9.95 cm2 |
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.
Time frame: 22 days (1 day after final treatment at day 21)
Population: Data collected for those participants with senile purpura for both interventions, data collected for those participants without for only the control no treatment arm
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BBL Treatment | Epidermal Thickness 1 Day After the Fourth BBL Treatment | 54.89 um |
| No Treatment | Epidermal Thickness 1 Day After the Fourth BBL Treatment | 45.31 um |
| No Treatment No Senile Purpura | Epidermal Thickness 1 Day After the Fourth BBL Treatment | 53.82 um |