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

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ClinicalTrials.gov Identifier: NCT01688076
Recruitment Status : Active, not recruiting
First Posted : September 19, 2012
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Forehead Rhytid Complex Glabellar Rhytid Complex Procedure: Botulinum Toxin A Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2012
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: Muscle contractions
Under supervision by study personnel, subjects be asked to make active muscle contractions for one hour after Botox injections. Subjects will return for follow-up visits.
Procedure: Botulinum Toxin A
Forehead will be injected with Botox.

Active Comparator: No muscle contractions
Patients will be asked to not perform muscle contractions following Botox injections.
Procedure: Botulinum Toxin A
Forehead will be injected with Botox.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01688076


Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Murad Alam, MD Northwestern University

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Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University
ClinicalTrials.gov Identifier: NCT01688076     History of Changes
Other Study ID Numbers: STU56722
First Posted: September 19, 2012    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents