Overview

This trial is active, not recruiting.

Condition wrinkles
Treatments onabotulinum toxin a, incobotulinum toxin a
Sponsor Northwestern University
Start date November 2013
End date November 2016
Trial size 20 participants
Trial identifier NCT02019004, STU83962

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
One side of the face will be randomized to receive Onabotulinum Toxin A injections in the forehead and glabellar region of the face.
onabotulinum toxin a Botox
(Active Comparator)
The other side of the face will be randomized to receive Incobotulinum Toxin A injections in the glabellar and forehead region of the face.
incobotulinum toxin a Xeomin

Primary Outcomes

Measure
Change in glabellar wrinkle score from baseline to 6 months for botox vs. xeomin
time frame: At baseline and at 6 months
Change in forehead wrinkle score from baseline to 6 months for botox vs. xeomin
time frame: At baseline and at 6 months

Eligibility Criteria

Male or female participants from 20 years up to 65 years old.

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

Additional Information

Official title Treatment of Forehead/Glabellar Rhytide Complex With Onabotulinum Toxin A Versus Incobotulinum Toxin A Injection: A Split-face, Double-blinded, Randomized Control Trial
Principal investigator Murad Alam, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Northwestern University.