Comparison of Escalating Doses of IncobotulinumtoxinA (Xeomin®) in the Treatment of Glabellar Rhytids

Status unconfirmed · Phase 4

Conditions studied: Skin Aging, Elastosis Senilis

In brief

The objective of the study is to compare the efficacy and duration of escalating doses of IncobotulinumtoxinA (Xeomin®) in the treatment of glabellar rhytids (frown lines between the eyes). Fifteen subjects will be enrolled in the study; specifically 60 male or female patients 18 years of age or older with moderate to severe glabellar rhytids at maximum contracture. Each patient will be randomized to receive one of 5 doses of Xeomin®, in a one-time dose to the treatment area. The efficacy endpoints will be determined by investigator and subject live assessment of the glabellar rhytids at rest and maximum contraction at each visit (every other day for 6 days post-injection, every month for 9 months following) using a validated 4 point photographic scale (minimal wrinkles \[0\], mild wrinkles \[1\], moderate wrinkles \[2\], or severe wrinkles \[3\]) used in previous studies. A written description of each photograph will be included to help standardize the application of the Photographic Scale.

Key facts

Study ID: NCT01583478
Run by: The Maas Clinic
People needed: 15
Starts: 2014-09-01
Expected to finish: 2015-12-01
Last updated by the study team: 2014-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Male or female patients who meet all of the following criteria are eligible for this study:
Eighteen years of age or older.
Moderate to severe vertical glabellar lines at maximum frown (score of [2] or [3] by physician assessment)
Negative pregnancy test for females of childbearing potential.
Time and ability to complete the study and comply with instructions.
Understanding of the study and contents of the informed consent.

You may not qualify if…

Patients who meet any of the following criteria are not eligible for this study:
Previous treatment to the glabellar area with Dysport® or Botox® Cosmetic or other botulinum toxin within 90 days of entry into the study. Botulinum toxin treatment of areas other than the glabellar area at any time during the study.
Patients with an ongoing treatment-related AE from any Dysport® or Botox® Cosmetic or botulinum toxin study.
Inability to substantially lessen glabellar lines by physically spreading them apart.
Soft tissue augmentation of the glabellar area (e.g. collagen-type implants, or hyaluronic acid fillers) at any time during the current study.
Permanent or semi-permanent dermal fillers in the glabellar area at any time.
Ablative skin resurfacing on the glabellar area at any time preceding the study or planning to during the current study.
Upper eyelid blepharoplasty or brow-lift at any time preceding the study or planning to during the current study.
Non-ablative treatments in the glabellar area for skin dyschromias (e.g. Intense Pulsed Light, light-emitting diodes) at any time during the current study.
Non-ablative dermal treatment in the glabellar area for skin tightening (e.g. radiofrequency treatments at any time preceding the current study or plan to have this done during the current study)
Retinoid, microdermabrasion, or prescription-level glycolic acid treatments to the glabellar area within 2 weeks prior to study participation or during the current study.
Concurrent therapy that, in the investigator's opinion, would interfere with evaluation of the efficacy or safety of the medication.
Active infection of the glabellar area (e.g. acute acne lesions or ulcers).
Pregnant women, nursing mothers, or women who are planning pregnancy during the study, or think they may be pregnant at the start of the study. Throughout the course of the study, women of childbearing potential must use reliable forms of contraception (e.g. abstinence, oral contraceptives for more than 12 consecutive weeks prior to enrollment, or spermicide and condoms).
Current history of chronic drug or alcohol abuse.
Enrollment in any active study involving the use of investigational devices or drugs.
Current facial palsy.
Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin.
Neuromuscular junctional disorders (myasthenia gravis).
Known allergy or hypersensitivity to any botulinum toxin or any component of Dysport® or Botox® Cosmetic.
Clinically diagnosed anxiety disorder, or any other significant psychiatric disorder (e.g. depression) that, in the opinion of the investigator, might interfere with the patient's participation in the study.
Concurrent use of medications that affect neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases affecting the striated muscle, and aminoglycoside antibiotics.
Presence of any condition (e.g. neuromuscular disorder or other disorder that could interfere with neuromuscular function) or circumstance that, in the judgment of the investigator, might increase the risk to the patient or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.

Where it is running

The Maas Clinic — San Francisco, California, United States (enrolling)

Full record on ClinicalTrials.gov

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