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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by The Maas Clinic
Sponsor:
Collaborator:
Merz Pharmaceuticals, LLC
Information provided by (Responsible Party):
Corey S. Maas, M.D., The Maas Clinic
ClinicalTrials.gov Identifier:
NCT01583478
First received: March 20, 2012
Last updated: September 27, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Skin Aging
Elastosis Senilis
Biological: incobotulinumtoxinA
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Pilot Study to Compare the Efficacy of Escalating Doses of IncobotulinumtoxinA (Xeomin®) in the Treatment of Glabellar Rhytids

Resource links provided by NLM:


Further study details as provided by The Maas Clinic:

Primary Outcome Measures:
  • Efficacy of escalating doses of Xeomin® in the treatment of glabellar rhytids [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Investigator and subject assessed grading


Secondary Outcome Measures:
  • Duration of action of escalating doses of Xeomin® in the treatment of glabellar rhytids [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Investigator and subject assessed grading

  • Safety and presence of any adverse effects of Xeomin® in the treatment of glabellar rhytids [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: September 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: incobotulinumtoxinA 20 units
Three patients will be randomly assigned to receive 20 units total of incobotulinumtoxinA to the glabellar region.
Biological: incobotulinumtoxinA
Eligible patients will receive Xeomin® doses of 20-, 40-, 60-, 80- or 100-units divided among 5 injection points (0.25 mL total) in the glabellar region on Day 0 of the study.
Other Name: Xeomin®
Active Comparator: incobotulinumtoxinA 40 units
Three patients will be randomly assigned to receive 40 units total of incobotulinumtoxinA to the glabellar region.
Biological: incobotulinumtoxinA
Eligible patients will receive Xeomin® doses of 20-, 40-, 60-, 80- or 100-units divided among 5 injection points (0.25 mL total) in the glabellar region on Day 0 of the study.
Other Name: Xeomin®
Active Comparator: incobotulinumtoxinA 60 units
Three patients will be randomly assigned to receive 60 units total of incobotulinumtoxinA to the glabellar region.
Biological: incobotulinumtoxinA
Eligible patients will receive Xeomin® doses of 20-, 40-, 60-, 80- or 100-units divided among 5 injection points (0.25 mL total) in the glabellar region on Day 0 of the study.
Other Name: Xeomin®
Active Comparator: incobotulinumtoxinA 80 units
Three patients will be randomly assigned to receive 80 units total of incobotulinumtoxinA to the glabellar region.
Biological: incobotulinumtoxinA
Eligible patients will receive Xeomin® doses of 20-, 40-, 60-, 80- or 100-units divided among 5 injection points (0.25 mL total) in the glabellar region on Day 0 of the study.
Other Name: Xeomin®
Active Comparator: incobotulinumtoxinA 100 units
Three patients will be randomly assigned to receive 100 units total of incobotulinumtoxinA to the glabellar region.
Biological: incobotulinumtoxinA
Eligible patients will receive Xeomin® doses of 20-, 40-, 60-, 80- or 100-units divided among 5 injection points (0.25 mL total) in the glabellar region on Day 0 of the study.
Other Name: Xeomin®

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583478

Locations
United States, California
The Maas Clinic Recruiting
San Francisco, California, United States, 94115
Contact: Kristin Fuller    415-567-8275    research@maasclinic.com   
Principal Investigator: Corey S Maas, MD         
Sub-Investigator: Jason P Champagne, MD         
Sponsors and Collaborators
The Maas Clinic
Merz Pharmaceuticals, LLC
Investigators
Principal Investigator: Corey S Maas, MD The Maas Clinic
  More Information

No publications provided

Responsible Party: Corey S. Maas, M.D., Director, The Maas Clinic
ClinicalTrials.gov Identifier: NCT01583478     History of Changes
Other Study ID Numbers: ITGR-2012
Study First Received: March 20, 2012
Last Updated: September 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by The Maas Clinic:
incobotulinumtoxinA
wrinkles
glabellar
rhytids
frown
lines

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014