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

Early Phase 1Active Not RecruitingNCT02019004

Northwestern University20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Wrinkles

Interventions

Onabotulinum Toxin ADRUG

Incobotulinum Toxin ADRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Females and males 2. In good health 3. Is 20-65 years of age 4. Has static and moderate dynamic forehead/glabellar wrinkles 5. Has willingness and the ability to understand and provide informed consent and communicate with the study staff Exclusion Criteria: 1. Pregnant or lactating 2. Younger than 20 or older than 65 years of age 3. Has received the following treatments in the forehead or glabellar region: 1. botulinum toxin injections in the past 6 months 2. ablative laser procedure in the past 6 months 3. radiofrequency device treatment in the past 6 months 4. ultrasound device treatment in the past 6 months 5. medium to deep chemical peel in the past 6 months 6. temporary soft tissue augmentation material in the area to be treated in the past year 7. semi-permanent soft tissue augmentation material in the area to be treated in the past 2 years 8. permanent soft tissue augmentation material in the area to be treated 4. 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. 5. Is planning to use tretinoin or retinoic acid in the next 6 months 6. Has an active infection in the forehead or glabellar region (excluding mild acne) 7. Is allergic to cow's milk protein 8. Is allergic to albumin 9. Taking aminoglycoside 10. Is currently using anticoagulation therapy 11. Has a history of bleeding disorders 12. Has a mental illness 13. Unable to understand the protocol or to give informed consent

Locations (1)

Northwestern University Department of Dermatology

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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 1. mild facial wrinkles 2. moderate facial wrinkles 3. severe facial wrinkling

Time frame: 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 1. minimal wrinkles 2. mild wrinkles 3. moderate wrinkles 4. severe wrinkles

Time frame: At baseline and at 6 months

Data from ClinicalTrials.gov

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