NCT05071274

A Proof of Concept Study to Evaluate the Efficacy and Tolerability of Microneedling With SkinPen in Female and Male Subjects With Facial Acne Vulgaris, Ages 18 Through 45

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Crown Laboratories, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This single-center, proof of concept trial is being conducted over the course of 42 days followed by a 2-month post-last treatment visit in order to assess the efficacy and tolerability of the Sponsor's SkinPen device in treating Acne Vulgaris on the face.

Detailed description

This single-center, proof of concept trial is being conducted over the course of 42 days followed by a 2-month post-last treatment visit in order to assess the efficacy and tolerability of the Sponsor's SkinPen device in treating Acne Vulgaris on the face. There is currently no published medical or scientific literature demonstrating the effect of Microneedling on Acne Vulgaris. The pathogenesis of acne is attributed to four major factors: (i)sebaceous gland hyperplasia; (ii) abnormal follicular hyperkeratinization; (iii) Propionibacterium acnes; and (iv) inflammatory and immune reactions. Increased sebum secretion is a major cause associated with the development of acne. Conventional treatments include topical retinoids, benzoyl peroxide, azelaic acid, and oral antibiotics and retinoids. However, most of these treatments take a long time to achieve a cure, and, recently, increasing resistance to antibiotics and isotretinoin's teratogenic potential have limited the use of traditional treatment. This proof of Concept study serves to evaluate the efficacy and tolerability of Microneedling with SkinPen in female and male Subjects with facial Acne Vulgaris, ages 18 through 45. Overall assessment of clinical outcome and safety will be based on clinic visits. The Investigator will apply an objective and precise assessment, the Lesion Count of inflammatory and non-inflammatory lesions.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DEVICE	Skinpen Prescision System	Skinpen Precision is an automated nonsurgical micro needling device designed for use by licensed health care practitioners or individuals directed by practitioners. The device incorporates a sterile Microneedle cartridge and Biosheath for single use only.

Timeline

• Start date: 2021-03-15
• Primary completion: 2022-03-18
• Completion: 2022-03-18
• First posted: 2021-10-08
• Last updated: 2022-03-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study