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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
One side of subject's face will randomly be assigned combination treatment.
Other side of subjects face with receive Botulinum Toxin A treatment alone.
Alejandra Onate
Chicago, Illinois, United States
Measure:
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.
Time frame: 1 year
Measure: Percent Improvement
* 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.
Time frame: 1 year
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