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Trial record 13 of 13 for:    "Supravalvular Aortic Stenosis"

Broad Band Light With and Without Radiofrequency Microneedling for Treating Senile Purpura

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ClinicalTrials.gov Identifier: NCT03690375
Recruitment Status : Active, not recruiting
First Posted : October 1, 2018
Last Update Posted : October 1, 2018
Sponsor:
Collaborator:
University of Miami
Information provided by (Responsible Party):
Siperstein Dermatology

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Senile Purpura Bateman's Purpura Device: Radiofrequency Microneedling Device: Broad Band Light (BBL) Not Applicable

Detailed Description:

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 30, 2018
Estimated Primary Completion Date : October 15, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BBL Only
Treatment with BBL only
Device: Broad Band Light (BBL)
Sciton BBL treatment using a new protocol that utilizes a 590nm, 560nm, and skintyte filter

Active Comparator: BBL with RFM
Treatment with BBL and Radiofrequency Microneedling
Device: Radiofrequency Microneedling
Cutera Secret Radiofrequency Microneedling Treatment

Device: Broad Band Light (BBL)
Sciton BBL treatment using a new protocol that utilizes a 590nm, 560nm, and skintyte filter




Primary Outcome Measures :
  1. The Efficacy of BBL or BBL in Addition to Radiofrequency Microneedling in Decreasing the Number of Lesions of Senile Purpura One Month After Treatment as Compared to Baseline. [ Time Frame: 51 Days BBL only Arm and another 72 Days for the BBL and MRF Arm ]
    The difference in the number of ecchymoses on the treated forearm 1 month after the last treatments as compared to baseline before treatment will be compared for each group.

  2. The Efficacy of BBL or BBL in Addition to Microneedling Radiofrequency in Decreasing the Total Square Size of senile purpura lesions one month after treatment as compared to baseline. [ Time Frame: 51 Days BBL only Arm and another 72 Days for the BBL and MRF Arm ]
    The difference in the total square size of all ecchymotic lesions on the treated forearm 1 month after the last treatments as compared to baseline before treatment will be compared for each group.


Secondary Outcome Measures :
  1. Change in epidermal thickness 1 day after the fourth BBL treatment [ Time Frame: 22 days ]
    Measurement of epidermal thickness on the BBL treated skin as compared to the control arm as measured by H&E stained sections using the AxionVision image analysis software.

  2. Change in DNA expression 1 day after the fourth BBL treatment [ Time Frame: 22 days ]
    Total RNA will be extracted and measurement in change of gene expression levels after treatment as compared to baseline will be calculated and normalized to a housekeeping gene and analyzed using a t test of means and SEM.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03690375


Locations
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United States, Florida
Siperstein Dermatology Group
Boynton Beach, Florida, United States, 33472
Sponsors and Collaborators
Siperstein Dermatology
University of Miami
Investigators
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Study Director: Robyn Siperstein, MD Siperstein Dermatology/ University of Miami

Publications:

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Responsible Party: Siperstein Dermatology
ClinicalTrials.gov Identifier: NCT03690375     History of Changes
Other Study ID Numbers: Purpura001
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Siperstein Dermatology:
skin atrophy
broad band bight
ecchymosis
collagen
elastin
RNA

Additional relevant MeSH terms:
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Purpura
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms