A Pilot Study Testing Onabotulinum Toxin A Versus Incobotulinum Toxin A Injections for Facial Wrinkles

Study Overview
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Brief Summary
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The purpose of this study is to compare the effectiveness of Botox® (Onabotulinum Toxin A) versus Xeomin® (incobotulinum toxin A) for the treatment of forehead and glabellar (vertical lines between the eyebrows) wrinkles.

Detailed Description
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Subjects will be screened, photographed, assessed, and randomized to be injected with onabotulinum toxin A on one side and incobotulinum toxin A on the other side during their first clinic visit. Subjects will return for a 2 week, 2 month, 3 month, 4 month, 5 month, and 6 month follow-up to have photographs taken by the unblinded research assistant at relaxed and full contraction. This study is a pilot study designed to determine feasibility of these procedures.

Official Title
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Treatment of Forehead/Glabellar Rhytide Complex With Onabotulinum Toxin A Versus Incobotulinum Toxin A Injection: A Split-face, Double-blinded, Randomized Control Trial

Conditions
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Wrinkles

Intervention / Treatment
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* Drug: Onabotulinum Toxin A
* Drug: Incobotulinum Toxin A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females and males In good health Is 20-65 years of age Has static and moderate dynamic forehead/glabellar wrinkles Has willingness and the ability to understand and provide informed consent and communicate with the study staff Exclusion Criteria: Pregnant or lactating Younger than 20 or older than 65 years of age 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 area to be treated in the past year semi-permanent soft tissue augmentation material in the area to be treated in the past 2 years permanent soft tissue augmentation material in the area to be treated 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 Is currently using anticoagulation therapy Has a history of bleeding disorders Has a mental illness Unable to understand the protocol or to give informed consent

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Onabotulinum Toxin A<br>One side of the face will be randomized to receive Onabotulinum Toxin A injections in the forehead and glabellar region of the face. | Drug: Onabotulinum Toxin A<br> <br> * Other names: Botox;|
| Active Comparator: Incobotulinum Toxin A<br>The other side of the face will be randomized to receive Incobotulinum Toxin A injections in the glabellar and forehead region of the face. | Drug: Incobotulinum Toxin A<br> <br> * Other names: Xeomin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glabellar wrinkle score from baseline to 6 months for botox vs. xeomin | Two blinded dermatologists will rate each photograph of each subject at baseline and at month 6. The glabellar wrinkle rating is: 0: no facial wrinkles mild facial wrinkles moderate facial wrinkles severe facial wrinkling | At baseline and at 6 months | 
| Change in forehead wrinkle score from baseline to 6 months for botox vs. xeomin | Two blinded dermatologists will rate each photograph of each subject at baseline and at month 6. The forehead wrinkle Merz rating is: 0: no wrinkles minimal wrinkles mild wrinkles moderate wrinkles severe wrinkles | At baseline and at 6 months |