Solar PurpuraNCT04912219
Microneedling for Dermatoporosis
A study testing Microneedling in people with Solar Purpura, run by The Cooper Health System.
Trial summary
We hypothesize that a series of treatments with a microneedling protocol will lead to increased dermal thickness as measured by biopsy, ultrasound, and skin calipometry; an improvement in dermatology-related quality of life; and a reduction in the number of ecchymoses and skin tears, of the research subjects. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Solar Purpura
- What is being tested?
- Microneedling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients will be eligible for inclusion in the study if they are age 60 or older and have dermatoporosis of the dorsal forearms as defined by any or all of the following: white pseudoscars, senile purpura, or skin atrophy.
Who cannot join
- Exclusion criteria: Patients with liver disease, heart disease, active infection, keloid predisposition, immunosuppression, genetic predisposition to poor wound healing, active cancer in the treatment area, bleeding disorders, pregnancy or nursing, taking the medication isotretinoin, with open wounds, sores or irritated skin in the treatment area, allergy to stainless steel or anesthetics, or skin phototype 4 or greater will be excluded from the study.
Trial locations and contacts
No sites are listed yet.
About this study
We hypothesize that a series of treatments with a microneedling protocol will lead to increased dermal thickness as measured by biopsy, ultrasound, and skin calipometry; an improvement in dermatology-related quality of life; and a reduction in the number of ecchymoses and skin tears, of the research subjects.
Read the detailed description
Dermatoporosis is a common condition, affecting between 30-37% of the population greater than age 65. It may lead to easy bruising, skin tearing, infections, and scars.
The pathogenesis of dermatoporosis involves decreased expression of collagen I, collagen III, and collagen IV; upregulation of matrix metalloproteinases 1, 2, and 3; downregulation of issue inhibitor of matrix metalloprotein I; loss of elastic tissue; defective fibroblast synthesis of collagen; and loss of hyaluronic acid.
Microneedling, also known as percutaneous collagen induction therapy, is a safe, established technique for treatment of acne scarring, rhytides, cellulite, and improvement of skin texture.
Microneedling has been demonstrated to stimulate growth factor release and increase dermal collagen and elastic fibers. It is effective in improving facial laxity, acne scarring, and facial rhytides.
Microneedling is safe and well tolerated. Expected adverse events include bleeding and oozing of the skin surface, redness, swelling, and peeling. Reported complications include post-inflammatory pigmentary changes, granulomatous reactions and systemic hypersensitivity reactions.
References:
- Wollina U, Lotti T, Vojvotic A, Nowak A. Dermatoporosis - The Chronic Cutaneous Fragility Syndrome. Open Access Maced J Med Sci. 2019;7(18):3046-3049.
- Dyer JM, Miller RA. Chronic Skin Fragility of Aging: Current Concepts in the Pathogenesis, Recognition, and Management of Dermatoporosis. J Clin Aesthet Dermatol. 2018;11(1):13-18.
- McCrudden MT, McAlister E, Courtenay AJ, Gonzalez-Va ́zquez P, Singh TR, Donnelly RF Microneedle applications in improving skin appearance. Exp Dermatol 2015;24(8):561-566.
- Doddaballapur S. Microneedling with dermaroller. J Cutan AesthetSurg 2009;2:110-1.10
- Aust MC, Reimers K, Kaplan HM, Stahl F, et al. Percutaneous collageninduction-regeneration in place of cicatrisation? J Plast Reconstr Aesthet Surg 2011;64:97-107.11.
- Schwarz M, Laaff H. A prospective controlled assessment of microneedling with the Dermaroller device. Plast Reconstr Surg 2011;127:146e-148e.14.
- Hou A, Cohen B, Haimovic A, Elbuluk N. Microneedling: A Comprehensive Review. Dermatol Surg. 2017 Mar;43(3):321-339
- Conditions
- Solar Purpura
- Being tested
- Microneedling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroneedlingDevice
Skin will be pretreated with topical 15% lidocaine creaml for 20 minutes. Water-soaked gauze will then be used to remove the lidocaine gel. Treated skin will be cleaned with 70% ethyl alcohol, allowed to dry, and then treated with hyaluronic acid gel.
Manual traction will be applied to the skin of the treatment arm, and the SkinPen microneedle device with 0.5mm microneedles attached will be passed over the forearm skin in a cross-hatch pattern until an endpoint of fine pinpoint bleeding is achieved.
Manual pressure with sterile ice water compresses will be used until hemostasis is achieved.
This will be repeated for a total of four treatments one month apart
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: Microneedling |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin thickness
Thickness of skin as measured by skin biopsy
Measured: one year
Skin thickness ultrasound
Thickness of skin as measured by ultrasound
Measured: 6 months
Secondary outcomes (2)
Dermatology-related quality of life
Dermatology quality of life index
Measured: six months and one year
Number of ecchymoses
Number of ecchymoses
Measured: six months and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start1 Aug 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solar 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cooper Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard M McLarney, MD, Principal investigator, Resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912219
- Sponsor's protocol ID
- Cooper-Microneedling
- Status last verified
- May 2021
- First submitted
- 28 May 2021
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microneedling for Dermatoporosis
- ClinicalTrials.gov ID
- NCT04912219
- Acronym / sponsor ID
- Cooper-Microneedling
- Conditions
- Solar Purpura
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- The Cooper Health SystemUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hypothesize that a series of treatments with a microneedling protocol will lead to increased dermal thickness as measured by biopsy, ultrasound, and skin calipometry; an improvement in dermatology-related quality of life; and a reduction in the number of ecchymoses and skin tears, of the research subjects.
Detailed description
Dermatoporosis is a common condition, affecting between 30-37% of the population greater than age 65. It may lead to easy bruising, skin tearing, infections, and scars.
The pathogenesis of dermatoporosis involves decreased expression of collagen I, collagen III, and collagen IV; upregulation of matrix metalloproteinases 1, 2, and 3; downregulation of issue inhibitor of matrix metalloprotein I; loss of elastic tissue; defective fibroblast synthesis of collagen; and loss of hyaluronic acid.
Microneedling, also known as percutaneous collagen induction therapy, is a safe, established technique for treatment of acne scarring, rhytides, cellulite, and improvement of skin texture.
Microneedling has been demonstrated to stimulate growth factor release and increase dermal collagen and elastic fibers. It is effective in improving facial laxity, acne scarring, and facial rhytides.
Microneedling is safe and well tolerated. Expected adverse events include bleeding and oozing of the skin surface, redness, swelling, and peeling. Reported complications include post-inflammatory pigmentary changes, granulomatous reactions and systemic hypersensitivity reactions.
References:
- Wollina U, Lotti T, Vojvotic A, Nowak A. Dermatoporosis - The Chronic Cutaneous Fragility Syndrome. Open Access Maced J Med Sci. 2019;7(18):3046-3049.
- Dyer JM, Miller RA. Chronic Skin Fragility of Aging: Current Concepts in the Pathogenesis, Recognition, and Management of Dermatoporosis. J Clin Aesthet Dermatol. 2018;11(1):13-18.
- McCrudden MT, McAlister E, Courtenay AJ, Gonzalez-Va ́zquez P, Singh TR, Donnelly RF Microneedle applications in improving skin appearance. Exp Dermatol 2015;24(8):561-566.
- Doddaballapur S. Microneedling with dermaroller. J Cutan AesthetSurg 2009;2:110-1.10
- Aust MC, Reimers K, Kaplan HM, Stahl F, et al. Percutaneous collageninduction-regeneration in place of cicatrisation? J Plast Reconstr Aesthet Surg 2011;64:97-107.11.
- Schwarz M, Laaff H. A prospective controlled assessment of microneedling with the Dermaroller device. Plast Reconstr Surg 2011;127:146e-148e.14.
- Hou A, Cohen B, Haimovic A, Elbuluk N. Microneedling: A Comprehensive Review. Dermatol Surg. 2017 Mar;43(3):321-339
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Microneedling |
| Control | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients will be eligible for inclusion in the study if they are age 60 or older and have dermatoporosis of the dorsal forearms as defined by any or all of the following: white pseudoscars, senile purpura, or skin atrophy.
Key exclusion criteria (1 listed)
- Exclusion criteria: Patients with liver disease, heart disease, active infection, keloid predisposition, immunosuppression, genetic predisposition to poor wound healing, active cancer in the treatment area, bleeding disorders, pregnancy or nursing, taking the medication isotretinoin, with open wounds, sores or irritated skin in the treatment area, allergy to stainless steel or anesthetics, or skin phototype 4 or greater will be excluded from the study.
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 |
|---|---|---|
| MicroneedlingSkin will be pretreated with topical 15% lidocaine creaml for 20 minutes. Water-soaked gauze will then be used to remove the lidocaine gel. Treated skin will be cleaned with 70% ethyl alcohol, allowed to dry, and then treated with hyaluronic acid gel. Manual traction will be applied to the skin of the treatment arm, and the SkinPen microneedle device with 0.5mm microneedles attached will be passed over the forearm skin in a cross-hatch pattern until an endpoint of fine pinpoint bleeding is achieved. Manual pressure with sterile ice water compresses will be used until hemostasis is achieved. This will be repeated for a total of four treatments one month apart | Device | Treatment |
Primary outcome
Skin thickness
Time frame: one year
Thickness of skin as measured by skin biopsy
Skin thickness ultrasound
Time frame: 6 months
Thickness of skin as measured by ultrasound
2 secondary outcomes
Dermatology-related quality of life
Time frame: six months and one year
Number of ecchymoses
Time frame: six months and one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- 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.
Richard M McLarney, MD principal investigator
Resident
Questions about this trial
What is this clinical trial studying?
A study testing Microneedling in people with Solar Purpura, run by The Cooper Health System.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard M McLarney, MD (956-802-0558, matt.mclarney@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin thickness (time frame: one year). 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?
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 3 Jun 2021.