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

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.

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

Conditions
-----------------
Forehead/Glabellar Rhytid Complexes

Intervention / Treatment
-----------------
* Procedure: Combination Botulinum Toxin A and Hyaluronic Acid
* Procedure: Botulinum Toxin A


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination Botulinum Toxin A and Hyaluronic Acid<br>One side of face treated with the combination of Botulinum Toxin A and Hyaluronic Acid injections. | Procedure: Combination Botulinum Toxin A and Hyaluronic Acid<br>* One side of subject's face will randomly be assigned combination treatment.<br>|
| Active Comparator: Botulinum Toxin A alone<br>Other side of face treated with =Botulinum Toxin A injection alone. | Procedure: Botulinum Toxin A<br>* Other side of subjects face with receive Botulinum Toxin A treatment alone.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year |