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Clinical Trials/NCT01186835
NCT01186835CompletedNot Applicable

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

Northwestern University2 sites in 1 country20 target enrollmentStarted: February 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
2
Primary Endpoint
Measure:

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Measure:

Time Frame: 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 Outcomes

  • Measure: Percent Improvement(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Murad Alam

Associate Professor of Dermatology

Northwestern University

Study Sites (2)

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