NCT06420804

Evaluation of the Safety and Efficacy of an Acne Treatment Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: ZIIP Beauty · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

A 50-patient study in which 400 microamps of direct current was applied 3 days per week. All tolerability, safety and efficacy endpoints were met.

Detailed description

A 50-patient study in which 400 microamps of direct current, applied 3 days per week on non-consecutive days, on all areas afflicted by acne. The results were as follow: TOLERABILITY ASSESSMENT The tolerability endpoint was the investigator-assessed absence of skin irritation from the facial study device at any time during the 12-week study. The tolerability endpoint was met. No statistically significant skin irritation was observed by the dermatologist investigator at any time during the study. SAFETY ASSESSMENT The safety endpoint was the absence of significant adverse reactions. No adverse reactions occurred. The safety endpoint was met. EFFICACY ASSESSMENT The efficacy endpoint was the investigator assessed improvement in investigator global assessment (IGA) after 12 weeks of every other day device use as compared to baseline. The efficacy endpoint was met. There was a 62% reduction in inflammatory lesions and a 49% reduction in noninflammatory lesions at week 12. The IGA was reduced by 44% after 12 weeks of device use from a baseline average of 2.56 to a week 12 average of 1.42. The ZIIP Acne Treatment Study was conducted in compliance with 21 CFR Parts 50, 56 and 812. No protocol deviations were reported during the ZIIP Acne Treatment Study.

Conditions

• Mild to Moderate Acne

Interventions

Type	Name	Description
DEVICE	ZIIP Acne Treatment Device	Evaluation of the Safety and Efficacy of a ZIIP Acne Treatment Device

Timeline

• Start date: 2020-10-15
• Primary completion: 2021-09-01
• Completion: 2021-10-03
• First posted: 2024-05-20
• Last updated: 2024-05-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study