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

Not Applicable

Completed

• Conditions: Forehead/Glabellar Rhytid Complexes
• Interventions: Procedure: Botulinum Toxin A; Procedure: Combination Botulinum Toxin A and Hyaluronic Acid

• Registration Number: NCT01186835
• Lead Sponsor: Northwestern University

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 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-08-19
• Study First Submitted QC: 2010-08-19
• Study First Posted: 2010-08-23
• Study Start: 2011-02
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-01
• Last Update Posted: 2021-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Botulinum Toxin A alone	Botulinum Toxin A	Other side of face treated with =Botulinum Toxin A injection alone.
Combination Botulinum Toxin A and Hyaluronic Acid	Combination Botulinum Toxin A and Hyaluronic Acid	One side of face treated with the combination of Botulinum Toxin A and Hyaluronic Acid injections.

Primary Outcome Measures

Name	Time	Method
Measure:	1 year	Two blinded dermatologists will rate each photograph of each subject at baseline, week 2, month 3, and month 6. The raters will provide a glabellar wrinkle score and a forehead wrinkle score for each photograph. The raters will not know what treatments the subjects received or at what point in time the photographs were taken.

Secondary Outcome Measures

Name	Time	Method
Measure: Percent Improvement	1 year	* Two blinded dermatologists will also rate the percent improvement between the before and after photographs (Appendix III).; * A live blinded dermatologist will determine which side looks better at week 0, week 2, month 3, and month 6.; * A subject self-evaluation will be administered at week 2, month 3, and month 6.; * A subject satisfaction questionnaire will be administered at month 6.

Trial Locations

Locations (1)

Alejandra Onate; 🇺🇸 Chicago, Illinois, United States