Broad Band Light With and Without Radiofrequency Microneedling for Treating Senile Purpura
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 10/3/2018 |
| Start Date: | August 30, 2018 |
| End Date: | December 30, 2018 |
A Prospective, Randomized, Split-Arm Pilot Study Investigating the Efficacy and Safety of Sciton's Broad Band Light With and Without Cutera's Radiofrequency Microneedling for Improving the Clinical Signs of Senile Purpura
There will be five subjects, each with at least one ecchymotic lesion on each arm measuring
at least one cm, who will be randomized to undergo 4 Sciton Broad Band Light (BBL) treatments
on either their left or right arm one week apart followed by 4 treatments of both BBL and
radiofrequency microneedling (RFM) on the opposite arm 2 weeks 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 and 3 months after their last treatments for final
pictures of their lower arms and evaluations.
at least one cm, who will be randomized to undergo 4 Sciton Broad Band Light (BBL) treatments
on either their left or right arm one week apart followed by 4 treatments of both BBL and
radiofrequency microneedling (RFM) on the opposite arm 2 weeks 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 and 3 months 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 5 subjects will
be randomized to which arm will be treated with Sciton's BBL only and the other arm will be
treated with both Sciton's BBL and Cutera's RFM.
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, 1 month, and 3 months 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, 7 days, and 14 days after the first treatment
A final assessment will be done by taking two skin biopsies from the subjects with sterile
instruments, one on treated skin and one on untreated skin. 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).
be randomized to which arm will be treated with Sciton's BBL only and the other arm will be
treated with both Sciton's BBL and Cutera's RFM.
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, 1 month, and 3 months 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, 7 days, and 14 days after the first treatment
A final assessment will be done by taking two skin biopsies from the subjects with sterile
instruments, one on treated skin and one on untreated skin. 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).
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 >50
- In good general health as evidenced by medical history
- Ecchymosis greater than 1cm on each arm
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
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