Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420804
Status:
COMPLETED
Last Update Posted:
2024-05-20
First Post:
2024-05-14
Brief Title:
Evaluation of the Safety and Efficacy of an Acne Treatment Device
Sponsor:
ZIIP Beauty
Organization:
ZIIP Beauty
Study Overview
Official Title:
Evaluation of the Safety and Efficacy of an Acne Treatment Device
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 256 to a week 12 average of 142
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
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 256 to a week 12 average of 142
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None