Broad Band Light for the Treatment and Prevention of Senile Purpura

April 10, 2021 updated by: Siperstein Dermatology

A Prospective, Randomized, Split-Arm Pilot Study Investigating the Efficacy and Safety of Sciton's Broad Band Light for Improving the Clinical Signs of Senile Purpura

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Siperstein Dermatology Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BBL Left
Left arm selected to be treated with BBL, right arm not treated
Device: Broad Band Light (BBL)
Sciton's BBL treatment using a new protocol that utilizes a 590nm, 560nm, and skintyte filter
Experimental: BBL Right
Right arm selected to be treated with BBL, left arm not treated
Device: Broad Band Light (BBL)
Sciton's BBL treatment using a new protocol that utilizes a 590nm, 560nm, and skintyte filter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change From Baseline to 30 Days After the Last Treatment in the Number of Senile Purpura Lesions
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)
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
Time Frame: 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.
51 Days (30 days after the final treatment at Day 21)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epidermal Thickness 1 Day After the Fourth BBL Treatment
Time Frame: 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.
22 days (1 day after final treatment at day 21)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siperstein Dermatology

Collaborators

University of Miami

Investigators

  • Study Director: Robyn Siperstein, MD, Siperstein Dermatology/ University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2018

Primary Completion (Actual)

October 15, 2019

Study Completion (Actual)

November 11, 2019

Study Registration Dates

First Submitted

September 22, 2018

First Submitted That Met QC Criteria

September 27, 2018

First Posted (Actual)

October 1, 2018

Study Record Updates

Last Update Posted (Actual)

April 13, 2021

Last Update Submitted That Met QC Criteria

April 10, 2021

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Purpura001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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