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

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

Sponsors

Lead Sponsor: Siperstein Dermatology

Collaborator: University of Miami

Source 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.

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).

Overall Status Completed
Start Date August 30, 2018
Completion Date November 11, 2019
Primary Completion Date October 15, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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. 51 Days BBL only Arm and another 72 Days for the BBL and MRF Arm
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. 51 Days BBL only Arm and another 72 Days for the BBL and MRF Arm
Secondary Outcome
Measure Time Frame
Change in epidermal thickness 1 day after the fourth BBL treatment 22 days
Change in DNA expression 1 day after the fourth BBL treatment 22 days
Enrollment 5
Condition
Intervention

Intervention Type: Device

Intervention Name: Radiofrequency Microneedling

Description: Cutera Secret Radiofrequency Microneedling Treatment

Arm Group Label: BBL with RFM

Intervention Type: Device

Intervention Name: Broad Band Light (BBL)

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

Eligibility

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

Gender: All

Minimum Age: 50 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Robyn Siperstein, MD Study Director Siperstein Dermatology/ University of Miami
Location
Facility: Siperstein Dermatology Group
Location Countries

United States

Verification Date

November 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: BBL Only

Type: Experimental

Description: Treatment with BBL only

Label: BBL with RFM

Type: Active Comparator

Description: Treatment with BBL and Radiofrequency Microneedling

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov