A Safety and Efficacy Study of OnabotulinumtoxinA in Upper Facial Rhytides

Completed · Phase 3 · Has a placebo group

Conditions studied: Facial Rhytides, Glabellar Rhytides

In brief

This is a safety and efficacy study of onabotulinumtoxinA in subjects with upper facial rhytides (forehead lines, glabellar lines, lateral canthal lines \[crow's feet lines\]).

Key facts

Study ID

NCT02261493

Run by

Allergan

People needed

787

Starts

2014-10-27

Expected to finish

2016-04-20

Last updated by the study team

2017-07-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Moderate to severe forehead lines, glabellar lines, and crow's feet lines
• Willing to have facial photos taken

You may not qualify if…

• Prior exposure to botulinum toxin of any serotype for any indication
• Anticipated need for treatment with botulinum toxin of any serotype for any indication during the study, other than study treatment
• Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
• Any facial resurfacing laser or light treatment, microdermabrasion, or superficial peels in the past 3 months
• Any medium depth or deep depth facial chemical peels; facial skin resurfacing; or permanent facial make-up in the past 6 months
• Any nonpermanent soft tissue fillers, or treatment with oral retinoids in the past year - Prior face lift, thread lift, eyebrow lift, or related procedures (eg, eyelid and/or eyebrow surgery)
• Prior facial treatment with permanent soft tissue fillers, synthetic implants (eg, Gore-Tex®), and/or fat transplantation

Where it is running

• The Petrus Center for Aesthetic — Little Rock, Arkansas, United States
• Westside Aesthetics — Los Angeles, California, United States
• Eye Research Foundation — Newport Beach, California, United States
• Steve Yoelin, MD Medical Associates, Inc. — Newport Beach, California, United States
• Baumann Cosmetic & Research Institute — Miami, Florida, United States
• Saint Louis University — St Louis, Missouri, United States
• The Center For Dermatology Cosmetic and Laser Surgery — Mount Kisco, New York, United States
• Tennessee Clinical Research Center — Nashville, Tennessee, United States
• The Center for Skin Research — Houston, Texas, United States
• Premier Clinical Research — Spokane, Washington, United States
• Aalst Dermatology Clinic — Aalst, Belgium
• UZ Brussel — Jette, Belgium
• Medical Skin Care - Sint-Truiden — Limbourg, Belgium
• Rosenpark Research — Darmstadt, Germany
• Hautzentrum Koeln (Cologne Dermatology) — Köln Nordrhein-Westfalen, Germany
• Hautok und hautok-cosmetics — München, Germany
• Praxisgemeinschaft Theatiner46 — München, Germany
• Hautzentrum am Starnberger See GmbH — Starnberg, Germany
• CentroDerm Study Center — Wuppertal, Germany
• Shakespeare House Health Centre, General Practice — Basingstoke, United Kingdom
• Medizen Clinic — Birmingham, United Kingdom
• The Bosham Clinic — Chichester, United Kingdom
• Waverlery Medical Practice — Coatbridge, United Kingdom
• The Gatehouse — Whitegate, United Kingdom

Full record on ClinicalTrials.gov

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