Patient Satisfaction With Treatment of BOTOX® Cosmetic for the Temporary Correction of Moderate to Severe Glabellar Lines
This study has been completed.
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00856414
First received: March 4, 2009
Last updated: November 8, 2011
Last verified: November 2011
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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 4, 2009 | ||||
| Last Updated Date | November 8, 2011 | ||||
| Start Date ICMJE | March 2009 | ||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
Onset of efficacy will be measured by patient diary and physician assessment at clinic visits [ Time Frame: Days 2,3,4,7,14 ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00856414 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Patient satisfaction will be measured by FLO, SPA and PGA [ Time Frame: Days 2, 3, 4, 7, 14 ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Patient Satisfaction With Treatment of BOTOX® Cosmetic for the Temporary Correction of Moderate to Severe Glabellar Lines | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | This study evaluates the patient satisfaction and onset of effect following treatment with botulinum toxin Type A in the treatment of glabellar rhytids (frown lines) |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Skin Aging | ||||
| Intervention ICMJE | Biological: botulinum toxin Type A
20U, up to two injections administered intramuscularly into the glabella (2 in each side of the corrugators and 1 in the procerus)
Other Name: BOTOX® |
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| Study Arm (s) | Experimental: 1
botulinum toxin Type A 20U
Intervention: Biological: botulinum toxin Type A |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 45 | ||||
| Completion Date | April 2009 | ||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 35 Years to 55 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00856414 | ||||
| Other Study ID Numbers ICMJE | MA-BTX-0806 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Allergan | ||||
| Study Sponsor ICMJE | Allergan | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Allergan | ||||
| Verification Date | November 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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