NCT05830968

Safety and Efficacy of Radio Frequency for the Treatment of Mild to Severe Inflammatory Acne

Clinical Evaluation of Safety and Efficacy of the InMode RF Pro System With the Morpheus8 Applicator for the Treatment of Mild to Severe Inflammatory Acne Vulgaris

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: InMode MD Ltd. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

The aim of this trial is to evaluate the safety and efficacy of the InMode RF Pro System with the Morpheus8 face tip (24 pins) applicator for the treatment of mild, moderate and severe, facial acne vulgaris

Detailed description

The aim of this trial is to evaluate the safety and efficacy of the InMode RF Pro System with the Morpheus8 face tip (24 pins) applicator for the treatment of mild, moderate and severe, facial acne vulgaris. Prospective, multicenter clinical study

Conditions

• Inflammatory Acne Vulgaris

Interventions

Type	Name	Description
DEVICE	Morpheus8 Applicator Radiofrequency device	Eligible subjects will receive 2 treatments with the Morpheus8 according to the study protocol. All participants will return for 2 follow up visits: 4 weeks (1M FU) and 12 weeks (3M FU) after the 2nd treatment. Total expected study duration is \~6 months, depending on subject recruitment rate.

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-05-01
• Completion: 2026-05-01
• First posted: 2023-04-26
• Last updated: 2024-05-29

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study