Clinical trial NCT03690375: Broad Band Light for the Treatment and Prevention of Senile Purpura
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Senile Purpura
Bateman's Purpura
Keywords: skin atrophy
broad band bight
ecchymosis
collagen
elastin
RNA
Lead sponsor: Siperstein Dermatology
Sponsor class: OTHER
Collaborators: name: University of Miami
First posted: 2018-10-01
Enrollment: 10
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

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 \>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

Primary outcomes:
measure: The Change From Baseline to 30 Days After the Last Treatment in the Number of Senile Purpura Lesions
timeFrame: 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)
measure: The Change in Total Square Size of Purpuric Lesions From Baseline to 30 Days After the Last Treatment
timeFrame: 51 Days (30 days after the final treatment at Day 21)
Secondary outcomes:
measure: Epidermal Thickness 1 Day After the Fourth BBL Treatment
timeFrame: 22 days (1 day after final treatment at day 21)
Other outcomes:
Locations:
city: Boynton Beach
country: United States
facility: Siperstein Dermatology Group
state: Florida
Study officials:
affiliation: Siperstein Dermatology/ University of Miami
name: Robyn Siperstein, MD
role: STUDY_DIRECTOR
References:
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citation: Chang AL, Bitter PH Jr, Qu K, Lin M, Rapicavoli NA, Chang HY. Rejuvenation of gene expression pattern of aged human skin by broadband light treatment: a pilot study. J Invest Dermatol. 2013 Feb;133(2):394-402. doi: 10.1038/jid.2012.287. Epub 2012 Aug 30.
citation: Prieto VG, Sadick NS, Lloreta J, Nicholson J, Shea CR. Effects of intense pulsed light on sun-damaged human skin, routine, and ultrastructural analysis. Lasers Surg Med. 2002;30(2):82-5. doi: 10.1002/lsm.10042.