Broad Band Light for the Treatment and Prevention of Senile Purpura

NCT03690375 | Completed Results FDA Device

• 1 other identifier: Purpura001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Senile Purpura; Bateman's Purpura

Keywords

skin atrophy; broad band bight; ecchymosis; collagen; elastin; RNA

Outcome Measures

Primary Outcomes (2)

• The Change From Baseline to 30 Days After the Last Treatment in the Number of Senile Purpura Lesions

  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

  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 Outcomes (1)

• Epidermal Thickness 1 Day After the Fourth BBL Treatment

  22 days (1 day after final treatment at day 21)

Study Arms (2)

BBL Left

EXPERIMENTAL

Left arm selected to be treated with BBL, right arm not treated

Device: Broad Band Light (BBL)

BBL Right

EXPERIMENTAL

Right arm selected to be treated with BBL, left arm not treated

Device: Broad Band Light (BBL)

Interventions

Broad Band Light (BBL) DEVICE

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

BBL Left; BBL Right

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Siperstein Dermatology: lead
• University of Miami: collaborator

Study Sites (1)

Siperstein Dermatology Group

Boynton Beach, Florida, 33472, United States

Location

Related Publications (7)

• Faucz LL, Will SE, Rodrigues CJ, Hesse H, Moraes AC, Maria DA. Quantitative evaluation of collagen and elastic fibers after intense pulsed light treatment of mouse skin. Lasers Surg Med. 2018 Jan 16. doi: 10.1002/lsm.22782. Online ahead of print.

  PMID: 29336034 BACKGROUND

• Bitter PH. Noninvasive rejuvenation of photodamaged skin using serial, full-face intense pulsed light treatments. Dermatol Surg. 2000 Sep;26(9):835-42; discussion 843. doi: 10.1046/j.1524-4725.2000.00085.x.

  PMID: 10971556 BACKGROUND

• McKenzie NE, Saboda K, Duckett LD, Goldman R, Hu C, Curiel-Lewandrowski CN. Development of a photographic scale for consistency and guidance in dermatologic assessment of forearm sun damage. Arch Dermatol. 2011 Jan;147(1):31-6. doi: 10.1001/archdermatol.2010.392.

  PMID: 21242389 BACKGROUND

• DeFatta RJ, Krishna S, Williams EF 3rd. Pulsed-dye laser for treating ecchymoses after facial cosmetic procedures. Arch Facial Plast Surg. 2009 Mar-Apr;11(2):99-103. doi: 10.1001/archfacial.2008.538.

  PMID: 19289681 BACKGROUND

• Brauer JA, Farhadian JA, Bernstein LJ, Bae YS, Geronemus RG. Pulsed Dye Laser at Subpurpuric Settings for the Treatment of Pulsed Dye Laser-Induced Ecchymoses in Patients With Port-Wine Stains. Dermatol Surg. 2018 Feb;44(2):220-226. doi: 10.1097/DSS.0000000000001255.

  PMID: 28858925 BACKGROUND

• 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.

  PMID: 22931923 BACKGROUND

• 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.

  PMID: 11870785 BACKGROUND

MeSH Terms

Conditions

Ecchymosis; Aortic Stenosis, Supravalvular

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Limitations and Caveats

Small pilot study

Results Point of Contact

• Title: founder/physician
• Organization: Siperstein Dermatology Group

info@sipderm.com

5613647774

Study Officials

• Robyn Siperstein, MD

  Siperstein Dermatology/ University of Miami

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2018
• First Posted: October 1, 2018
• Study Start: August 27, 2018
• Primary Completion: October 15, 2019
• Study Completion: November 11, 2019
• Last Updated: April 13, 2021
• Results First Posted: April 13, 2021

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)