NCT01814670

Brief Summary

A study to evaluate safety and efficacy of treatment with botulinum toxin Type A (BOTOX®) in Chinese patients with moderate to severe frown lines (Glabellar Rhytides) previously treated with facial laser resurfacing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

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

March 6, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2014

Completed
10 months until next milestone

Results Posted

Study results publicly available

September 1, 2015

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

1.4 years

First QC Date

March 18, 2013

Results QC Date

August 5, 2015

Last Update Submit

April 3, 2019

Conditions

Glabellar Rhytides

Outcome Measures

Primary Outcomes (1)

  • Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction

    The Investigator assessed the severity of the subject's glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.

    Day 1, Day 30

Secondary Outcomes (4)

  • Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction

    Day 1, Day 14, Day 90, Day 120

  • Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction

    Day 1, Day 14, Day 30, Day 90, Day 120

  • Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest

    Day 1, Day 14, Day 30, Day 90, Day 120

  • Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest

    Day 1, Day 14, Day 30, Day 90, Day 120

Study Arms (1)

botulinum toxin Type A

EXPERIMENTAL

20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.

Biological: botulinum toxin Type A

Interventions

botulinum toxin Type ABIOLOGICAL

20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.

Also known as: BOTOX®, onabotulinumtoxinA
botulinum toxin Type A

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • moderate or severe frown lines
  • facial laser treatment between 4 to 8 weeks prior to Day 1

You may not qualify if:

  • previous use of botulinum toxin for any indication
  • diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
  • microdermabrasion or superficial peels, permanent make-up to the brow and forehead area within the last 3 months
  • facial cosmetic procedures within the last 6 Months
  • treatment to forehead, brow, nose or midface areas with any filler within the last 12 months
  • use of a new topical skin care product within 1 month of the screening
  • any prior forehead or periorbital surgery or brow lift
  • deep dermal scarring, excessively thick sebaceous skin, and/ or loss of skin elasticity
  • any facial skin infection or unhealed skin lesion
  • pregnant or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Beijing, China

Location

Related Publications (1)

  • Wu Y, Lu Z, Xie Y, Zhang W, Chen X, Shi Y, Li Q, Halstead M, Rogers JD, Silberberg M. OnabotulinumtoxinA treatment of moderate to severe glabellar lines in Chinese subjects after laser therapy: A prospective, open-label, noncomparative study. J Cosmet Laser Ther. 2018 Oct;20(5):278-286. doi: 10.1080/14764172.2017.1406604. Epub 2018 Mar 2.

    PMID: 29498553BACKGROUND

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Results Point of Contact

Title
Vice President Medical Affairs,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2013

First Posted

March 20, 2013

Study Start

March 6, 2013

Primary Completion

July 31, 2014

Study Completion

October 29, 2014

Last Updated

April 17, 2019

Results First Posted

September 1, 2015

Record last verified: 2019-04

Locations

CN(1)