N/A
N=20
Broad Band Light for the Treatment and Prevention of Senile Purpura
Senile Purpura · Bateman's Purpura
Bottom Line
View on ClinicalTrials.gov: NCT03690375 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: The Change From Baseline to 30 Days After the Last Treatment in the Number of Senile Purpura Lesions — -3.55; -.35 number of purpuric lesions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Broad Band Light (BBL) (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Siperstein Dermatology
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change From Baseline to 30 Days After the Last Treatment in the Number of Senile Purpura Lesions |
-3.55; -.35 | — |
| PRIMARY The Change in Total Square Size of Purpuric Lesions From Baseline to 30 Days After the Last Treatment |
-4.8; 9.95 | — |
| SECONDARY Epidermal Thickness 1 Day After the Fourth BBL Treatment |
54.89; 45.31; 53.82 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03690375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.