Ignite Creation Date:
2024-05-06 @ 9:11 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02924428
Status:
TERMINATED
Last Update Posted:
2020-11-09
First Post:
2016-09-30
Brief Title:
Venus Versa Diamondpolar Applicator Treatment Followed by AC Dual Applicator Treatment for Facial Acne Vulgaris
Sponsor:
Venus Concept
Organization:
Venus Concept
Study Overview
Official Title:
Clinical Evaluation of Venus Versa Diamonpolar Applicator Treatment Followed by AC Dual Applicator Treatment Using 2 Intense Pulsed Light Wavelength Bands for Facial Acne Vulgaris
Status:
TERMINATED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
not commenced
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate the efficacy of facial acne vulgaris treatment using the Venus Versa Diamondpolar applicator in combination with the Venus Versa AC dual applicator using two intense pulsed light wavelength bands
Detailed Description:
Multi-center prospective open-label study utilizing before-after study design Up to 20 healthy subjects age 18 - 55 years with acne vulgaris who wish to improve their skin appearance will be randomized to receive either Diamondpolar applicator radio frequency and pulsed magnetic field treatment followed by AC Dual applicator intense pulsed light treatment or AC Dual applicator intense pulsed light treatment alone using the Venus Versa system Duration of subject participation will be approximately 10 weeks 4 weekly treatments with a follow-up visit scheduled 6 weeks after the last treatment
The AC Dual applicator IPL is indicated for the treatment of acne vulgaris by using a blue light 415 nm to target porphyrins produced by the P acne bacteria destroying the bacteria and uses the red light 630 nm to help reduce inflammation inhibit sebum production and improve healing
The addition of the Diamondpolar applicator RF and PEMF treatment is thought to target the sebaceous gland causing it to shrink and decrease sebum output
The AC Dual applicator IPL is indicated for the treatment of acne vulgaris by using a blue light 415 nm to target porphyrins produced by the P acne bacteria destroying the bacteria and uses the red light 630 nm to help reduce inflammation inhibit sebum production and improve healing
The addition of the Diamondpolar applicator RF and PEMF treatment is thought to target the sebaceous gland causing it to shrink and decrease sebum output
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None