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

NCT01583478 | Unknown Phase 4

• 1 other identifier: ITGR-2012
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Aging; Elastosis Senilis

Keywords

incobotulinumtoxinA; wrinkles; glabellar; rhytids; frown; lines

Outcome Measures

Primary Outcomes (1)

• Efficacy of escalating doses of Xeomin® in the treatment of glabellar rhytids

  Investigator and subject assessed grading

  12 months

Secondary Outcomes (2)

• Duration of action of escalating doses of Xeomin® in the treatment of glabellar rhytids

  12 months

• Safety and presence of any adverse effects of Xeomin® in the treatment of glabellar rhytids

  12 months

Study Arms (5)

incobotulinumtoxinA 20 units

ACTIVE COMPARATOR

Three patients will be randomly assigned to receive 20 units total of incobotulinumtoxinA to the glabellar region.

Biological: incobotulinumtoxinA

incobotulinumtoxinA 40 units

ACTIVE COMPARATOR

Three patients will be randomly assigned to receive 40 units total of incobotulinumtoxinA to the glabellar region.

Biological: incobotulinumtoxinA

incobotulinumtoxinA 60 units

ACTIVE COMPARATOR

Three patients will be randomly assigned to receive 60 units total of incobotulinumtoxinA to the glabellar region.

Biological: incobotulinumtoxinA

incobotulinumtoxinA 80 units

ACTIVE COMPARATOR

Three patients will be randomly assigned to receive 80 units total of incobotulinumtoxinA to the glabellar region.

Biological: incobotulinumtoxinA

incobotulinumtoxinA 100 units

ACTIVE COMPARATOR

Three patients will be randomly assigned to receive 100 units total of incobotulinumtoxinA to the glabellar region.

Biological: incobotulinumtoxinA

Interventions

incobotulinumtoxinA BIOLOGICAL

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.

Also known as: Xeomin®

incobotulinumtoxinA 100 units; incobotulinumtoxinA 20 units; incobotulinumtoxinA 40 units; incobotulinumtoxinA 60 units; incobotulinumtoxinA 80 units

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• The Maas Clinic: lead
• Merz North America, Inc.: collaborator

Study Sites (1)

The Maas Clinic

San Francisco, California, 94115, United States

RECRUITING

MeSH Terms

Interventions

incobotulinumtoxinA

Study Officials

• Corey S Maas, MD

  The Maas Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: April 24, 2012
• Study Start: September 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 30, 2014

Record last verified: 2014-09

Locations

US (1)