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OpenTrials
Completed

NCT Number: NCT01186835

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

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.

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Key information

Conditions

Forehead/Glabellar Rhytid Complexes

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alejandra Onate

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combination Botulinum Toxin A and Hyaluronic Acid

Procedure

One side of subject's face will randomly be assigned combination treatment.

Botulinum toxin A

Procedure

Other side of subjects face with receive Botulinum Toxin A treatment alone.

Primary outcomes

  1. 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

  1. Measure: Percent Improvement

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Medicis Pharmaceutical Corporation

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 23, 2010
Registry last updated
Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.