Treatment of Forehead/Glabellar Rhytide Complex With Combination Botulinum Toxin A and Hyaluronic Acid Versus Botulinum Toxin A Injection Alone

Completed · Not applicable

Conditions studied: Forehead/Glabellar Rhytid Complexes

In brief

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 forehead and glabella (area between the eyebrows) better than botulinum toxin alone. These two products have been FDA approved to improve the appearance of facial wrinkles.

Key facts

Study ID

NCT01186835

Run by

Northwestern University

People needed

20

Starts

2011-02-01

Expected to finish

2011-06-01

Last updated by the study team

2021-12-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alejandra Onate — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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