NCT04740255

Straberi Epistamp Device for Postinflammatory Hyperpigmentation

Clinical Trial Study for the Use of Straberi Epistamp Needling Device to Treat Postinflammatory Hyperpigmentation (PIH)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Universal Skincare Institute · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This pilot study will expand knowledge and application needling using the Straberi device for the improvement of Postinflammatory Hyperpigmentation (PIH) caused by acne.

Detailed description

This pilot study will expand the knowledge and application of needling using the Straberi Epistamp device and its safety and benefits for improving the appearance of Postinflammatory Hyperpigmentation. Postinflammatory Hyperpigmentation (PIH) caused by acne is a common inflammatory disease that can adversely affect facial appearance. Facial acne can have a serious negative impact on psychosocial functioning leaving deep emotional scars. Severe acne can also lead to physical scars and disfigurement. Among patients with severe acne, facial scarring affects both genders equally and occurs to some degree in 95% of cases.

Conditions

• Postinflammatory Hyperpigmentation

Interventions

Type	Name	Description
DEVICE	Straberi Epistamp	The patient's entire face will be treated. The following settings will be used as a treatment protocol. Needle length between .02- 1.55 mm

Timeline

• Start date: 2022-12-23
• Primary completion: 2023-06-30
• Completion: 2023-10-12
• First posted: 2021-02-05
• Last updated: 2023-12-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study