Clinical Trial to Evaluate the Safety and Efficacy of JTM... | NCT06246552

Studies
Clinical Trial to Evaluate the Safety and Efficacy of JTM201 to Treat Moderate or Severe Glabellar Lines

NCT06246552

Sponsor

Jetema USA Inc.

Status

Completed

Last Update Posted

Aug 29, 2025Actual

Enrollment

480Actual

Phase

Phase 2

Conditions

Glabellar Lines

Interventions

JTM201
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 26, 2024Actual

Primary Completion Date

Jun 5, 2025Actual

Completion Date

Jun 5, 2025Actual

First Submitted Date

Jan 30, 2024

First Submission Date that Met QC Criteria

Jan 30, 2024

First Posted Date

Feb 7, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2025

Last Update Posted Date

Aug 29, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is Multicenter, Randomized, Double-blind, Placebo-controlled, Single-dose Study to evaluate Safety and Efficacy of JTM201 in patients with Moderate or Severe Glabellar Lines

Detailed Description

This is Multicenter, Randomized, Double-blind, Placebo-controlled, Single-dose Study to evaluate Safety and Efficacy of JTM201 in patients with Moderate or Severe Glabellar Lines. Treatment period is 180 days and evaluation of the safety is the primary endpoint

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

480Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
JTM201	Experimental	Botulinum toxin	Biological: JTM201
Placebo	Placebo Comparator	Placebo	Biological: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JTM201	Biological	JTM201 20U in 0.5mL : JTM201 will be injected via IM in 5 glabellar location 0.1mL (4U / 0.1mL) at each location	JTM201

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
TEAE	Treatment-emergent AEs (TEAEs) from Baseline through end of followup	180 days
SAE	Serious AEs (SAEs) from the screening period through end of follow-up	180 days

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Glabellar Line Scale (GLS)	Proportion of subjects who achieve a ≥ 2-point improvement in GLS at maximum frown by IA and SSA from Baseline	30 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects ≥18 years of age based on the date of the written informed consent form.
Subject is able to provide written informed consent and comply with study procedures.
Subject has moderate or severe glabellar lines on maximum frown as assessed by the investigator and subject using the GLS (score of 2 or 3).

Exclusion Criteria:

Previous insertion of permanent material in the glabellar area including the forehead.
Planned treatment with botulinum toxin of any serotype in any other body region during the study period.
Pregnant or breastfeeding (directly or via pump); or planning to become pregnant during the study.
Known allergy or hypersensitivity to botulinum toxin or product excipients.
Participation in another interventional clinical study ≤30 days of Visit 1: Screening.
Planning to donate, bank, or retrieve eggs (ova, oocytes) or donate sperm during the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ablon Skin Institute & Research Center		Manhattan Beach	California	90266	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided