Microneedling for Dermatoporosis
Primary Purpose
Solar Purpura
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Microneedling
Sponsored by
About this trial
This is an interventional treatment trial for Solar Purpura
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Control
Arm Description
Outcomes
Primary Outcome Measures
Skin thickness
Thickness of skin as measured by skin biopsy
Skin thickness ultrasound
Thickness of skin as measured by ultrasound
Secondary Outcome Measures
Dermatology-related quality of life
Dermatology quality of life index
Number of ecchymoses
Number of ecchymoses
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04912219
Brief Title
Microneedling for Dermatoporosis
Official Title
Microneedling for Dermatoporosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cooper Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solar Purpura
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Microneedling
Intervention Description
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
Primary Outcome Measure Information:
Title
Skin thickness
Description
Thickness of skin as measured by skin biopsy
Time Frame
one year
Title
Skin thickness ultrasound
Description
Thickness of skin as measured by ultrasound
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Dermatology-related quality of life
Description
Dermatology quality of life index
Time Frame
six months and one year
Title
Number of ecchymoses
Description
Number of ecchymoses
Time Frame
six months and one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard M McLarney, MD
Phone
956-802-0558
Email
matt.mclarney@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Naomi Lawrence, MD
Phone
856-596-3040
Email
lawrence-naomi@cooperhealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard M McLarney, MD
Organizational Affiliation
Resident
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Microneedling for Dermatoporosis
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