Field of Effects of Two Commercial Preparations of Botulinum Toxin Type A
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00989768 |
Recruitment Status
:
Completed
First Posted
: October 6, 2009
Results First Posted
: April 27, 2010
Last Update Posted
: June 2, 2010
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | October 5, 2009 | |||
First Posted Date ICMJE | October 6, 2009 | |||
Results First Submitted Date | October 28, 2009 | |||
Results First Posted Date | April 27, 2010 | |||
Last Update Posted Date | June 2, 2010 | |||
Study Start Date ICMJE | May 2005 | |||
Actual Primary Completion Date | November 2007 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
|
|||
Original Primary Outcome Measures ICMJE |
|
|||
Change History | Complete list of historical versions of study NCT00989768 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE |
ECMAP in m. Frontialis BoNT A1(5U) X BoNT A2 (2U) [ Time Frame: 28 days ] | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Field of Effects of Two Commercial Preparations of Botulinum Toxin Type A | |||
Official Title ICMJE | Field Effects of Two Commercial Preparations of Botulinum Toxin Type a Administered to the Frontalis Muscles | |||
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 Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
|||
Condition ICMJE | Wrinkles in Frontal Area | |||
Intervention ICMJE |
|
|||
Study Arms | Experimental: Botulinum toxin type - A
Dysport® compared to Botox®
Interventions:
|
|||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
29 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | December 2007 | |||
Actual Primary Completion Date | November 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
Ages | 18 Years to 60 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Brazil | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00989768 | |||
Other Study ID Numbers ICMJE | 01-CBED06b | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Doris Hexsel, CBED | |||
Study Sponsor ICMJE | Brazilan Center for Studies in Dermatology | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | Brazilan Center for Studies in Dermatology | |||
Verification Date | October 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |