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Broad Band Light for the Treatment and Prevention of Senile Purpura

NCT03690375 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-04-13

Study results available
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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.

Conditions

  • Senile Purpura
  • Bateman's Purpura

Interventions

DEVICE

Broad Band Light (BBL)

Sciton's BBL treatment using a new protocol that utilizes a 590nm, 560nm, and skintyte filter

Sponsors & Collaborators

  • University of Miami

    collaborator OTHER

  • Siperstein Dermatology

    lead OTHER

Principal Investigators

  • Robyn Siperstein, MD · Siperstein Dermatology/ University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-27
Primary Completion
2019-10-15
Completion
2019-11-11
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03690375 on ClinicalTrials.gov