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Completed

NCT Number: NCT01688076

Treatment of Forehead/Glabellar Rhytide Complex With Botulinum Toxin A Injection

This cross-over design study will evaluate the onset of action, efficacy, and duration of botulinum toxin A treatment on forehead/glabellar rhytid complexes with and without subsequent muscle contraction.

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Key information

Conditions

Forehead Rhytid Complex Glabellar Rhytid Complex

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

About this study

In this cross-over design study, the investigators will evaluate whether active muscle contraction following Botox® injection of the forehead/glabellar rhytid complex will impact the onset of action, efficacy, and duration of Botox® treatment.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • In good health
  • Is 18-65 years of age
  • Has static and dynamic forehead/glabellar wrinkles
  • Has decided to receive Botox® treatment for their forehead/glabellar wrinkles
  • Has the willingness and ability to understand and provide informed consent and communicate with the investigator
  • Is willing to return for follow-up visits

Exclusion criteria

  • Pregnant or lactating
  • 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 past year
  • semi-permanent soft tissue augmentation material in the past 2 years
  • permanent soft tissue augmentation material
  • Is planning to receive within the next year, 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 year
  • 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
  • Is unable to understand the protocol or to give informed consent
  • Is unable to return for follow-up visits
  • Has a mental illness

Treatment and study plan

Botulinum toxin A

Procedure

Forehead will be injected with Botox.

Primary outcomes

  1. Measurement of Forehead Wrinkles with Honeck Four Point Rating Scale

    Time frame: 13 months

    A single dermatologist will rate each photograph of the subject's forehead/glabellar rhytid complex at baseline, 1 day, 2 days, 3 days, 4 days, 7 days, 2 weeks, 7 months and 1 day, 7 months and 2 days, 7 months and 3 days, 7 months and 4 days, 7 months and 7 days, and 7 months and 2 weeks. A glabellar wrinkle score and a forehead wrinkle score will be assigned to each photograph. The dermatologist will not know at what point in time the photographs were taken.

Secondary outcomes

  1. Number of Participants with Adverse Events

    Time frame: 13 months

    Side effects and adverse events will be assessed

  2. Level of Satisfaction

    Time frame: 7 months

    Patients will be asked to rate their satisfaction

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Treatment of Forehead/Glabellar Rhytide Complex With Botulinum Toxin A Injection: Impact of Muscle Contraction on Onset of Action, Efficacy, and Duration of Treatment

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
Sep 19, 2012
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.