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

Northwestern University

Status: Completed

Conditions: Forehead/Glabellar Rhytid Complexes

Treatments: Procedure: Combination Botulinum Toxin A and Hyaluronic Acid; Procedure: Botulinum Toxin A

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01186835

MA-stu24810

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Combination Botulinum Toxin A and Hyaluronic Acid

Experimental group

Description:

One side of face treated with the combination of Botulinum Toxin A and Hyaluronic Acid injections.

Treatment:

Procedure: Combination Botulinum Toxin A and Hyaluronic Acid

Botulinum Toxin A alone

Active Comparator group

Description:

Other side of face treated with =Botulinum Toxin A injection alone.

Treatment:

Procedure: Botulinum Toxin A