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

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:

MedlinePlus related topics: Botox

Drug Information available for: Hyaluronic Acid Hyaluronate Sodium OnabotulinumtoxinA

U.S. FDA Resources

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 May 23, 2013