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

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ClinicalTrials.gov Identifier: NCT01186835
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : May 23, 2014
Sponsor:
Collaborator:
Medicis Pharmaceutical Corporation
Information provided by (Responsible Party):
Murad Alam, 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.

Condition or disease Intervention/treatment Phase
Forehead/Glabellar Rhytid Complexes Procedure: Combination Botulinum Toxin A and Hyaluronic Acid Procedure: Botulinum Toxin A Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (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
Study Start Date : February 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox
U.S. FDA Resources

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Murad Alam, Associate Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT01186835     History of Changes
Other Study ID Numbers: MA-stu24810
First Posted: August 23, 2010    Key Record Dates
Last Update Posted: May 23, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Hyaluronic Acid
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors
Viscosupplements
Protective Agents
Neuromuscular Agents
Peripheral Nervous System Agents