Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines
This study has been completed.
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01189747
First received: August 25, 2010
Last updated: April 2, 2012
Last verified: April 2012
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Purpose
This study will evaluate the safety and efficacy of botulinum toxin type A compared to placebo for the treatment of Crow's Feet Lines (Lateral Canthal Rhytides).
| Condition | Intervention | Phase |
|---|---|---|
|
Lateral Canthus Rhytides Crow's Feet Lines |
Biological: botulinum toxin type A Drug: Normal Saline |
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 |
Resource links provided by NLM:
Further study details as provided by Allergan:
Primary Outcome Measures:
- Severity of Crow's Feet Lines at maximum smile using the Facial Wrinkle Scale [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Investigator's assessment of the severity of Crow's Feet Lines at rest using the Facial Wrinkle Scale [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
- Subject's Global Assessment of change in appearance of Crow's Feet Lines [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
- Subject's assessment of facial appearance [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
| Enrollment: | 446 |
| Study Start Date: | October 2010 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
botulinum toxin type A
|
Biological: botulinum toxin type A
24 units (total dose) injected into bilateral Crow's Feet Line areas on Day 1
Other Name: BOTOX® Cosmetic
|
|
Placebo Comparator: 2
Normal Saline
|
Drug: Normal Saline
Injected into bilateral Crow's Feet Line areas on Day 1
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Moderate to severe Crow's Feet Lines
- Have adequate vision without the use of eyeglasses to assess facial wrinkles in a mirror (contact lenses OK)
Exclusion Criteria:
- Current or previous botulinum toxin treatment of any serotype
- Facial laser or light treatment, microdermabrasion or superficial peels within 3 months
- Oral retinoid therapy within 1 year
- Prior facial cosmetic surgery (eg, periorbital surgery, facial lift, brow lift, eye lift, or eyebrow surgery)
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01189747
Locations
| United States, California | |
| Newport Beach, California, United States | |
| Belgium | |
| Aalst, Belgium | |
| Canada, British Columbia | |
| Vancouver, British Columbia, Canada | |
| United Kingdom | |
| Sutton Coldfield, England, United Kingdom | |
Sponsors and Collaborators
Allergan
Investigators
| Study Director: | Medical Director | Allergan |
More Information
No publications provided
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT01189747 History of Changes |
| Other Study ID Numbers: | 191622-098 |
| Study First Received: | August 25, 2010 |
| Last Updated: | April 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
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