Treatment of Forehead/Glabellar Rhytide Complex With Botulinum Toxin A Injection
This trial is active, not recruiting.
|Conditions||forehead rhytid complex, glabellar rhytid complex|
|Treatment||botulinum toxin a|
|Start date||January 2012|
|End date||December 2016|
|Trial size||25 participants|
|Trial identifier||NCT01688076, STU56722|
This cross-over design study will evaluate the onset of action, efficacy, and duration of botulinum toxin A treatment on forehead/glabellar rhytid complexes with and without subsequent muscle contraction.
|Intervention model||crossover assignment|
|Masking||single blind (outcomes assessor)|
Measurement of Forehead Wrinkles with Honeck Four Point Rating Scale
time frame: 13 months
Number of Participants with Adverse Events
time frame: 13 months
Level of Satisfaction
time frame: 7 months
Male or female participants from 18 years up to 65 years old.
Inclusion Criteria: - In good health - Is 18-65 years of age - Has static and dynamic forehead/glabellar wrinkles - Has decided to receive Botox® treatment for their forehead/glabellar wrinkles - Has the willingness and ability to understand and provide informed consent and communicate with the investigator - Is willing to return for follow-up visits Exclusion Criteria: - Pregnant or lactating - Has received the following treatments in the forehead or glabellar region: - botulinum toxin injections in the past 6 months - ablative laser procedure in the past 6 months - radiofrequency device treatment in the past 6 months - ultrasound device treatment in the past 6 months - medium to deep chemical peel in the past 6 months - temporary soft tissue augmentation material in the past year - semi-permanent soft tissue augmentation material in the past 2 years - permanent soft tissue augmentation material - Is planning to receive within the next year, any cosmetic procedure (such as any chemical peels, botulinum toxin injections, ablative or non-ablative laser procedures, filler injections, radiofrequency procedures, dermabrasion, ultrasound and face lifting procedures) in the forehead or glabellar region. - Is planning to use tretinoin or retinoic acid in the next year - Has an active infection in the forehead or glabellar region (excluding mild acne) - Is allergic to cow's-milk protein - Is allergic to albumin - Taking aminoglycoside - Is currently using anticoagulation therapy - Has a history of bleeding disorders - Is unable to understand the protocol or to give informed consent - Is unable to return for follow-up visits - Has a mental illness
|Official title||Treatment of Forehead/Glabellar Rhytide Complex With Botulinum Toxin A Injection: Impact of Muscle Contraction on Onset of Action, Efficacy, and Duration of Treatment|
|Principal investigator||Murad Alam, MD|
|Description||In this cross-over design study, the investigators will evaluate whether active muscle contraction following Botox® injection of the forehead/glabellar rhytid complex will impact the onset of action, efficacy, and duration of Botox® treatment.|
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