The Treatment of Glabellar Frown Lines
1 other identifier
interventional
250
1 country
10
Brief Summary
The purpose of this study is to show that two FDA-approved botulinum toxin drugs called Xeomin® and Botox® can reduce the severity of vertical lines (wrinkles) that appear between the eyebrows (glabellar frown lines).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2014
Shorter than P25 for phase_4
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 20, 2014
CompletedFirst Posted
Study publicly available on registry
March 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedResults Posted
Study results publicly available
March 16, 2017
CompletedOctober 19, 2017
September 1, 2017
6 months
March 20, 2014
September 8, 2016
September 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy, Measured as the Percentage of Participants Who Responded to Treatment
Response defined as ≥ 1 point improvement from baseline (prior to treatment) on the Facial Wrinkle Scale at maximum frown as rated by an independent masked panel of physicians specifically qualified to assess study photographs using subject photographs at 1 month from treatment.
1 Month from baseline
Secondary Outcomes (13)
Response at Maximum Frown Rated by Independent Rater
2 months from baseline
Response at Maximum Frown Rated by Independent Rater
3 months from baseline
Response at Maximum Frown Rated by Independent Rater
4 months from baseline
Response at Maximum Frown Rated by Treating Physician
1 month from baseline
Response at Maximum Frown Rated by Treating Physician
2 months from baseline
- +8 more secondary outcomes
Study Arms (2)
IncobotulinumtoxinA
EXPERIMENTAL20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points
OnabotulinumtoxinA
ACTIVE COMPARATOR20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points
Interventions
20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection
20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection
Eligibility Criteria
You may qualify if:
- Outpatient females 18 to 50 years of age
- Moderate to severe glabellar frown lines
You may not qualify if:
- Glabellar Frown Lines at rest rating 3 on the 4-point Facial Wrinkle Scale
- Previous treatment with botulinum toxin
- Previous treatment with biodegradable fillers in glabellar area within last 12 months
- Any severe or uncontrolled systemic disease, malignant tumor, or medical history of HIV infection
- Known hypersensitivity to incobotulinumtoxinA or onabotulinumtoxinA or to any of their excipients
- Intake of any of the forbidden concomitant medication or other agents that might interfere with neuromuscular function or might interfere with the action of botulinum toxin type within 14 days prior to injection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Merz Investigative Site #001099
Los Angeles, California, 90069, United States
Merz Investigative Site #001300
Sacramento, California, 95819, United States
Merz Investigative Site #001299
Santa Monica, California, 90404, United States
Merz Investigative Site #001298
Washington D.C., District of Columbia, 20005, United States
Merz Investigative Site #001170
Washington D.C., District of Columbia, 20037, United States
Merz Investigative Site #001101
Coral Gables, Florida, 33146, United States
Merz Investigative Site #001105
Metairie, Louisiana, 70006, United States
Merz Investigative Site #001098
Chestnut Hill, Massachusetts, 02467, United States
Merz Investigative Site #001297
New York, New York, 10065, United States
Merz Investigative Site #001097
Nashville, Tennessee, 37215, United States
Related Publications (1)
Kane MA, Gold MH, Coleman WP 3rd, Jones DH, Tanghetti EA, Alster TS, Rohrer TE, Burgess CM, Shamban AT, Finn E. A Randomized, Double-Blind Trial to Investigate the Equivalence of IncobotulinumtoxinA and OnabotulinumtoxinA for Glabellar Frown Lines. Dermatol Surg. 2015 Nov;41(11):1310-9. doi: 10.1097/DSS.0000000000000531.
PMID: 26509943RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michelle Widmann
- Organization
- Merz North America, Inc.
Study Officials
- STUDY DIRECTOR
Andrea Schlӧbe, MD
Merz North America, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2014
First Posted
March 26, 2014
Study Start
February 1, 2014
Primary Completion
August 1, 2014
Study Completion
November 1, 2014
Last Updated
October 19, 2017
Results First Posted
March 16, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share