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

NCT01583478 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2014-09-30

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Merz North America, Inc.

    collaborator INDUSTRY

  • The Maas Clinic

    lead OTHER

Principal Investigators

  • Corey S Maas, MD · The Maas Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-10-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01583478 on ClinicalTrials.gov