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

Wrinkles Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02019004
• Other study ID #: STU83962
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2013
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Wrinkles

Intervention

Drug:
• Onabotulinum Toxin A

• Incobotulinum Toxin A

Locations

Country	Name	City	State
United States	Northwestern University Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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