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

This study has been completed.
Sponsor:
Collaborator:
Medicis Pharmaceutical Corporation
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT01186835
First received: August 19, 2010
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Forehead/Glabellar Rhytid Complexes
Procedure: Combination Botulinum Toxin A and Hyaluronic Acid
Procedure: Botulinum Toxin A

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Measure: [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Measure: Percent Improvement [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    • 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.


Enrollment: 20
Study Start Date: February 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186835

Locations
United States, Illinois
Northwestern University Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Medicis Pharmaceutical Corporation
Investigators
Principal Investigator: Murad Alam, MD Northwestern University
  More Information

No publications provided

Responsible Party: Murad Alam, Associate Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT01186835     History of Changes
Other Study ID Numbers: MA-stu24810
Study First Received: August 19, 2010
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Botulinum Toxins
Hyaluronic Acid
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on April 17, 2014