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NCT Number: NCT02019004

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Wrinkles

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Females and males
  • In good health
  • Is 20-65 years of age
  • Has static and moderate dynamic forehead/glabellar wrinkles
  • Has willingness and the ability to understand and provide informed consent and communicate with the study staff

Exclusion criteria

  • Pregnant or lactating
  • Younger than 20 or older than 65 years of age
  • Has received the following treatments in the forehead or glabellar region:
  • botulinum toxin injections in the past 6 months
  • ablative laser procedure in the past 6 months
  • radiofrequency device treatment in the past 6 months
  • ultrasound device treatment in the past 6 months
  • medium to deep chemical peel in the past 6 months
  • temporary soft tissue augmentation material in the area to be treated in the past year
  • semi-permanent soft tissue augmentation material in the area to be treated in the past 2 years
  • permanent soft tissue augmentation material in the area to be treated
  • 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.
  • Is planning to use tretinoin or retinoic acid in the next 6 months
  • Has an active infection in the forehead or glabellar region (excluding mild acne)
  • Is allergic to cow's milk protein
  • Is allergic to albumin
  • Taking aminoglycoside
  • Is currently using anticoagulation therapy
  • Has a history of bleeding disorders
  • Has a mental illness
  • Unable to understand the protocol or to give informed consent

Treatment and study plan

Onabotulinum toxin A

Drug

Other names: Botox

Incobotulinum Toxin A

Drug

Other names: Xeomin

Primary outcomes

  1. Change in glabellar wrinkle score from baseline to 6 months for botox vs. xeomin

    Time frame: 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

    • mild facial wrinkles
    • moderate facial wrinkles
    • severe facial wrinkling

  2. Change in forehead wrinkle score from baseline to 6 months for botox vs. xeomin

    Time frame: 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

    • minimal wrinkles
    • mild wrinkles
    • moderate wrinkles
    • severe wrinkles

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2027
Study completion
2027
First posted
Dec 24, 2013
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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