Broad Band Light for the Treatment and Prevention of Senile Purpura (NCT03690375) | Clinical Trial Compass
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 range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
2
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)