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2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-02-28 @ 5:31 AM
Study NCT ID:
NCT00989768
Status:
COMPLETED
Last Update Posted:
2010-06-02
First Post:
2009-10-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Field of Effects of Two Commercial Preparations of Botulinum Toxin Type A
Sponsor:
Hexsel Dermatology Clinic
Organization:
Study Overview
Official Title:
Field Effects of Two Commercial Preparations of Botulinum Toxin Type a Administered to the Frontalis Muscles
Status:
COMPLETED
Status Verified Date:
2009-10
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:
The objective of this study is to compare the field of effects of the botulinum toxins (Dysport® and Botox®) using two equivalence-ratios and to gather supportive information, such as more detailed data on the effectiveness in reduction of wrinkles and duration of action on the upper part of the face of both products, trough scales and photographs evaluations.
Detailed Description:
This was a monocentric, prospective, randomized and double-blind study. Twenty nine female patients, presenting with moderate to severe forehead wrinkles, with sweating ability who had never undergone previous BoNT-A injections were enrolled. Subjects have received botulinum toxin type-A injections in two forehead sites, Botox 2U and Dysport 5U, both reconstituted in the same volume of 0.02 mL per point. Baseline, twenty-eight and 112 days later, clinical and photographic assessments, Minor´s test, and electromyographic (EMG) evaluations were performed.
Study Oversight
Has Oversight DMC:
False
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?: