CompletedNot Applicable

Broad Band Light for the Treatment and Prevention of Senile Purpura

United States10 participantsStarted 2018-08-27

Plain-language 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.

Who can participate

Age range22 Years

SexALL

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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

What they're measuring

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)

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)

Trial details

NCT IDNCT03690375

SponsorSiperstein Dermatology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10-15

Results submitted2020-11-15

View on ClinicalTrials.gov More Senile Purpura trials