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

Northwestern University

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Wrinkles

Treatments: Drug: Incobotulinum Toxin A; Drug: Onabotulinum Toxin A

Study type: Interventional

Funder types: Other

Identifiers

NCT02019004

STU83962

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Onabotulinum Toxin A

Active Comparator group

Description:

One side of the face will be randomized to receive Onabotulinum Toxin A injections in the forehead and glabellar region of the face.

Treatment:

Drug: Onabotulinum Toxin A

Incobotulinum Toxin A

Active Comparator group

Description:

The other side of the face will be randomized to receive Incobotulinum Toxin A injections in the glabellar and forehead region of the face.

Treatment:

Drug: Incobotulinum Toxin A