Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616311
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Efficacy of Radiofrequency Micro Needling for the Treatment of Melasma in Skin of Color
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Study of the Efficacy of Radiofrequency Micro Needling for the Treatment of Melasma in Skin of Color
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SylfirmX
Brief Summary:
The objective of this study is to test the effectiveness of radiofrequency microneedling RFMN as a treatment for melasma The Investigator hypothesize that RFMN will be an effective treatment for melasma in skin of color patients
Detailed Description:
The target population is skin of color patients with melasma Patients will receive 3 consecutive RFMN treatments over a period of three months Baseline melasma severity will be measured by the modified Melasma Area and Severity Index mMASI score Endpoints will be mMASI scores at 1 and 3 months post-procedure Patient reported outcomes will be measured using the melasma quality of life MelasQOL validated patient questionnaire at screening and at both follow up visits The long-term goal of future studies would be to provide melasma patients particularly those with skin of color with improved therapeutic options for the treatment of their melasma as compared to current treatment options
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