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

Treatment of Forehead/Glabellar Rhytide Complex with Onabotulinum Toxin a Versus Incobotulinum Toxin a Injection: a Split-face, Double-blinded, Randomized Control Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Wrinkles
• Intervention / Treatment: Drug: Onabotulinum Toxin A; Drug: Incobotulinum Toxin A

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Onabotulinum Toxin A; 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; Other Names: Botox
Active Comparator: Incobotulinum Toxin A; 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; Other Names: Xeomin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Murad Alam, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 12, 2013
• First Submitted That Met QC Criteria: December 23, 2013
• First Posted (Estimated): December 24, 2013

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: STU83962

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No