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
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Northwestern University
- 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
Murad Alam
Associate Professor of Dermatology
Northwestern University
Study Sites (2)
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