Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06331533
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2024-03-17
Brief Title:
Intradermal BoNT-A Treatment in Erythematotelangiectatic Rosacea
Sponsor:
Istanbul Training and Research Hospital
Organization:
Istanbul Training and Research Hospital
Study Overview
Official Title:
Effects of Botulinum Toxin Type a Treatment on Clinical and Biophysical Parameters in Patients With Erythematotelangiectatic Rosacea A Prospective Randomized Placebo-controlled Double-masked Study
Status:
COMPLETED
Status Verified Date:
2024-03
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:
Investigation of the effectiveness of intradermal botulinum toxin A treatment in the treatment of erythematotelangiectatic rosacea ETR using clinical biophysical dermatoscopic and videocapillaroscopy
Detailed Description:
There is no gold standard treatment for erythematotelangiectatic rosacea ETR In recent years some studies have been conducted to demonstrate the efficacy of intradermal botulinum toxin A BoNT-A treatment in ETR and facial erythema Studies including objective and quantitative measurements are limited
This study aims to investigate the efficacy and safety of intradermal BoNT-A treatment in ETR patients
This randomised double-blind split-face study included 30 participants with erythematotelangiectatic rosacea ETR They were randomly randomised to intradermal BoNT-A on one side of the face and placebo on the other side Clinicians erythema assessment CEA score patient self-assessment PSA score erythema index EI melanin index MI dermatoscopic and capillaroscopic analyses of background erythema and vascular structure were assessed at baseline and one month after treatment
This study aims to investigate the efficacy and safety of intradermal BoNT-A treatment in ETR patients
This randomised double-blind split-face study included 30 participants with erythematotelangiectatic rosacea ETR They were randomly randomised to intradermal BoNT-A on one side of the face and placebo on the other side Clinicians erythema assessment CEA score patient self-assessment PSA score erythema index EI melanin index MI dermatoscopic and capillaroscopic analyses of background erythema and vascular structure were assessed at baseline and one month after treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None