A Study Of BOTOX For The Treatment Of Glabellar Lines
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00408785
First received: December 6, 2006
Last updated: November 10, 2011
Last verified: November 2011
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Purpose
This is a Multicenter, double-blind, randomized, placebo-controlled, parallel-group comparative study to confirm the efficacy and safety of BOTOX 20 units single injection for the Chinese patients with glabellar lines. The subjects will receive a single intramuscular treatment consisting of 5 injections of either BOTOX? 20U or placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Glabellar Lines |
Drug: Botulinum Toxin Type A Drug: sodium chloride |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of BOTOX? (Botulinum Toxin Type A) in Subjects With Glabellar Lines |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- The investigator's rating of Glabellar line severity at maximum frown [ Time Frame: Day 30 after injection ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Investigator's rating of Glabellar line severity at rest, subject's global assessment of change in appearance of glabellar lines, the subject's perception of age and safety evaluations. [ Time Frame: Day 7, 30, 60, 90, 120 after injection ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 256 |
| Study Start Date: | November 2006 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Injection
|
Drug: Botulinum Toxin Type A
botulinum toxin type A 100 units, human serum albumin 0.5 mg, sodium chloride 0.9 mg
|
|
Placebo Comparator: B
Injection
|
Drug: sodium chloride
sodium chloride 0.9 mg
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Male and female adult with Glabellar lines of at least moderate severity at maximum frown by investigator's assessment.
Exclusion criteria:
- Patients with systemic nerve conduction junction disorder or patients with infection or other skin disease/surgery at injection sites will not be eligible.
- Patient with severe complications related to heart, kidney, liver disease or respiratory system will not be eligible.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00408785
Locations
| China | |
| GSK Investigational Site | |
| Beijing, China, 100853 | |
| GSK Investigational Site | |
| Beijing, China, 100034 | |
| GSK Investigational Site | |
| Beijing, China, 100036 | |
| GSK Investigational Site | |
| Shanghai, China, 200040 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00408785 History of Changes |
| Other Study ID Numbers: | 107457 |
| Study First Received: | December 6, 2006 |
| Last Updated: | November 10, 2011 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
Botulinum Toxin Type A safety efficacy glabellar lines |
Additional relevant MeSH terms:
|
Botulinum Toxins, Type A Botulinum Toxins Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013