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

Treatment of Forehead/Glabellar Rhytide Complex With Combination Botulinum Toxin A and Hyaluronic Acid Versus Botulinum Toxin A Injection Alone: A Split-face, Rater-blinded Randomized Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Forehead/Glabellar Rhytid Complexes
• Intervention / Treatment: Procedure: Combination Botulinum Toxin A and Hyaluronic Acid; Procedure: Botulinum Toxin A

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Alejandra Onate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination Botulinum Toxin A and Hyaluronic Acid; One side of face treated with the combination of Botulinum Toxin A and Hyaluronic Acid injections.	Procedure: Combination Botulinum Toxin A and Hyaluronic Acid; One side of subject's face will randomly be assigned combination treatment.
Active Comparator: Botulinum Toxin A alone; Other side of face treated with =Botulinum Toxin A injection alone.	Procedure: Botulinum Toxin A; Other side of subjects face with receive Botulinum Toxin A treatment alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure:	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure: Percent Improvement	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.	1 year

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Medicis Pharmaceutical Corporation

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: August 19, 2010
• First Submitted That Met QC Criteria: August 19, 2010
• First Posted (Estimate): August 23, 2010

Study Record Updates

• Last Update Posted (Actual): December 3, 2021
• Last Update Submitted That Met QC Criteria: December 1, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Immunologic Factors; Protective Agents; Membrane Transport Modulators; Adjuvants, Immunologic; Acetylcholine Release Inhibitors; Neuromuscular Agents; Viscosupplements; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; Hyaluronic Acid
• Other Study ID Numbers: MA-stu24810