Status:
COMPLETED
Treatment of Forehead/Glabellar Rhytide Complex With Combination Botulinum Toxin A and Hyaluronic Acid Versus Botulinum Toxin A Injection Alone
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Medicis Pharmaceutical Corporation
Conditions:
Forehead/Glabellar Rhytid Complexes
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The objective of this study is to determine whether the use of botulinum toxin (Dysport ®) in conjunction with a hyaluronic acid filler (Restylane®) will improve the appearance of wrinkles on the fore...
Eligibility Criteria
Inclusion
- In good health
- Is 18-65 years of age
- Has static and dynamic forehead/glabellar wrinkles
- Has willingness and the ability to understand and provide informed consent and communicate with the investigator
Exclusion
- 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 6 months, 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 6 months
- 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
- Has prior history of nodule formation or hypersensitivity reactions to lidocaine or hyaluronic acid derivatives
- Is currently using anticoagulation therapy
- Has a history of bleeding disorders
- Is unable to understand the protocol or to give informed consent
- Has a mental illness
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01186835
Start Date
February 1 2011
End Date
June 1 2011
Last Update
December 3 2021
Active Locations (1)
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1
Alejandra Onate
Chicago, Illinois, United States, 60611