NCT04912219

Microneedling for Dermatoporosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: The Cooper Health System · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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

Conditions

• Solar Purpura

Interventions

Type	Name	Description
DEVICE	Microneedling	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

Timeline

• Start date: 2021-08-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-06-03
• Last updated: 2021-06-03

Regulatory

• FDA-regulated device study