Senile PurpuraNCT03690375
Broad Band Light for the Treatment and Prevention of Senile Purpura
A study testing Broad Band Light (BBL) in people with Senile Purpura and Bateman's Purpura, run by Siperstein Dermatology at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Senile Purpura, Bateman's Purpura
- What is being tested?
- Broad Band Light (BBL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2018to 11 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Siperstein Dermatology Group
Boynton Beach, Florida, 33472
About this study
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
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.
Read the 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).
- Conditions
- Senile Purpura, Bateman's Purpura
- Being tested
- Broad Band Light (BBL)
- Keywords
- skin atrophy, broad band bight, ecchymosis, collagen, elastin, RNA
- Medical subject headings
- Ecchymosis, Aortic Stenosis, Supravalvular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broad Band Light (BBL)Device
Sciton's BBL treatment using a new protocol that utilizes a 590nm, 560nm, and skintyte filter
| Study group | Role | What they receive |
|---|---|---|
| BBL Left | Experimental | Left arm selected to be treated with BBL, right arm not treated Receives: Device: Broad Band Light (BBL) |
| BBL Right | Experimental | Right arm selected to be treated with BBL, left arm not treated Receives: Device: Broad Band Light (BBL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 51 Days (30 days after the final treatment at Day 21)
Secondary outcomes (1)
Epidermal Thickness 1 Day After the Fourth BBL Treatment
Measurement of epidermal thickness in um as measured by H\&E stained sections using the AxionVision image analysis software based on slides from biopsies taken from the subjects 1 days after their last treatment.
Measured: 22 days (1 day after final treatment at day 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start27 Aug 2018
- Primary completion15 Oct 2019
- Study completion11 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Senile PurpuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siperstein Dermatology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami
- Responsible party
- Sponsor
- Investigators
- Robyn Siperstein, MD, Study director, Siperstein Dermatology/ University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690375
- Sponsor's protocol ID
- Purpura001
- Status last verified
- Nov 2019
- First submitted
- 22 Sep 2018
- Last updated
- 13 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 29336034Bitter 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.
PubMed 10971556McKenzie 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.
PubMed 21242389DeFatta 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.
PubMed 19289681Brauer 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.
PubMed 28858925Chang 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.
PubMed 22931923Prieto 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.
PubMed 11870785
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03690375
- Acronym / sponsor ID
- Purpura001
- Conditions
- Senile Purpura, Bateman's Purpura
- Keywords
- skin atrophy, broad band bight, ecchymosis, collagen, elastin, RNA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Siperstein DermatologyUniversity, hospital or other
- Collaborators
- University of Miami
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 11 Nov 2019 (actual)
- First posted
- 1 Oct 2018 (actual)
- Results
- Posted 13 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BBL Left | Experimental | Device: Broad Band Light (BBL)Left arm selected to be treated with BBL, right arm not treated |
| BBL Right | Experimental | Device: Broad Band Light (BBL)Right arm selected to be treated with BBL, left arm not treated |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broad Band Light (BBL)Sciton's BBL treatment using a new protocol that utilizes a 590nm, 560nm, and skintyte filter | Device | BBL Left, BBL Right |
Primary outcome
The Change From Baseline to 30 Days After the Last Treatment in the Number of Senile Purpura Lesions
Time frame: 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 number of purpuric lesions 30 days after the last treatment will be subtracted from the number of purpuric lesions at baseline
The Change in Total Square Size of Purpuric Lesions From Baseline to 30 Days After the Last Treatment
Time frame: 51 Days (30 days after the final treatment at Day 21)
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.
1 secondary outcome
Epidermal Thickness 1 Day After the Fourth BBL Treatment
Time frame: 22 days (1 day after final treatment at day 21)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29336034Faucz 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.
- Background: PubMed 10971556Bitter 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.
- Background: PubMed 21242389McKenzie 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.
- Background: PubMed 19289681DeFatta 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.
- Background: PubMed 28858925Brauer 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.
- Background: PubMed 22931923Chang 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.
- Background: PubMed 11870785Prieto 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robyn Siperstein, MD study director
Siperstein Dermatology/ University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Broad Band Light (BBL) in people with Senile Purpura and Bateman's Purpura, run by Siperstein Dermatology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Change From Baseline to 30 Days After the Last Treatment in the Number of Senile Purpura Lesions (time frame: 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03690375, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.