Clinical trial NCT04912219: Microneedling for Dermatoporosis
Official title: Microneedling for Dermatoporosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Solar Purpura
Lead sponsor: The Cooper Health System
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 35
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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:

1. 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.
2. 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.
3. 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.
4. Doddaballapur S. Microneedling with dermaroller. J Cutan AesthetSurg 2009;2:110-1.10
5. 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.
6. Schwarz M, Laaff H. A prospective controlled assessment of microneedling with the Dermaroller device. Plast Reconstr Surg 2011;127:146e-148e.14.
7. Hou A, Cohen B, Haimovic A, Elbuluk N. Microneedling: A Comprehensive Review. Dermatol Surg. 2017 Mar;43(3):321-339

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.

Primary outcomes:
measure: Skin thickness
timeFrame: one year
measure: Skin thickness ultrasound
timeFrame: 6 months
Secondary outcomes:
measure: Dermatology-related quality of life
timeFrame: six months and one year
measure: Number of ecchymoses
timeFrame: six months and one year
Other outcomes:
Locations:
Study officials:
affiliation: Resident
name: Richard M McLarney, MD
role: PRINCIPAL_INVESTIGATOR
References: