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

Not Applicable

Active, not recruiting

• Conditions: Wrinkles
• Interventions: Drug: Onabotulinum Toxin A; Drug: Incobotulinum Toxin A

• Registration Number: NCT02019004
• Lead Sponsor: Northwestern University

Brief 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.

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 Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-12
• Study First Submitted QC: 2013-12-23
• Study First Posted: 2013-12-24
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Onabotulinum Toxin A	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.
Incobotulinum Toxin A	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.

Primary Outcome Measures

Name	Time	Method
Change in glabellar wrinkle score from baseline to 6 months for botox vs. xeomin	At baseline and at 6 months	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
Change in forehead wrinkle score from baseline to 6 months for botox vs. xeomin	At baseline and at 6 months	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

Trial Locations

Locations (1)

Northwestern University Department of Dermatology; 🇺🇸 Chicago, Illinois, United States