NCT04830345

Brief Summary

Efficacy and safety of ATGC-100 are assessed in subjects with moderate to severe glabellar lines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
290

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2020

Shorter than P25 for phase_3

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

June 29, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2021

Enrollment Period

1.2 years

First QC Date

March 31, 2021

Last Update Submit

March 22, 2022

Conditions

Glabellar Frown Lines

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with improvement of glabellar lines at maximum frown

    Improvement rate of glabellar lines at maximum frown with Physician's Facial wrinkle scale (FWS)

    4 weeks post injection compared to baseline

Study Arms (2)

ATGC-100 100U

EXPERIMENTAL

ATGC-100 will be injected to 5 glabellar lines (each 4U/0.1mL; total 20U) at Day 0

Biological: ATGC-100 100U

Botox 100U

ACTIVE COMPARATOR

Botox inj. will be injected to 5 glabellar lines (each 4U/0.1mL; total 20U) at Day 0

Biological: Botox 100U

Interventions

ATGC-100 100UBIOLOGICAL

Clostridium botulinum toxin type A

ATGC-100 100U
Botox 100UBIOLOGICAL

Clostridium botulinum toxin type A

Botox 100U

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male and female aged 19 to 65 years old
  • Participants with Facial Wrinkle Scale (FWS) score of \> 2 at maximum frown at screening
  • Participants willing to follow the study procedures and schedules
  • Participants willing to give written informed consent to participate in the trial

You may not qualify if:

  • Participants with severe glabellar lines that cannot be improved physical method
  • Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
  • Participants with known hypersensitivity to any component of the study drug
  • Participant who has skin disorder including infection and scar on injection site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nowon Eulji University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 3
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 31, 2021

First Posted

April 5, 2021

Study Start

June 29, 2020

Primary Completion

September 1, 2021

Study Completion

October 1, 2021

Last Updated

April 4, 2022

Record last verified: 2021-03

Locations

KR(1)