A Study of NT 201 in the Treatment of Enlarged Pores and... | NCT05784363

Studies
A Study of NT 201 in the Treatment of Enlarged Pores and Excessive Sebum Production in the Face

NCT05784363

Sponsor

Merz North America, Inc.

Status

Completed

Last Update Posted

Aug 23, 2024Actual

Enrollment

31Actual

Phase

Phase 1

Conditions

Enlarged Pores
Sebum Production

Interventions

NT 201
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 2024

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 27, 2022Actual

Primary Completion Date

Jun 17, 2024Actual

Completion Date

Jul 31, 2024Actual

First Submitted Date

Mar 13, 2023

First Submission Date that Met QC Criteria

Mar 13, 2023

First Posted Date

Mar 24, 2023Actual

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 21, 2024

Last Update Posted Date

Aug 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to investigate the efficacy and safety of NT 201 injections in the treatment of enlarged pores and excessive sebum production in the face.

Detailed Description

Eligible subjects will be randomized to one of the two treatment groups: NT 201 group and placebo in order to receive one session of injections with either NT 201 or placebo in the upper face (forehead and cheek area) on Day 1 and followed for about 90 days after treatment.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NT 201	Experimental	Single NT 201 injection treatment.	Drug: NT 201
Placebo	Placebo Comparator	Single placebo injection treatment.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NT 201	Drug	Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9 percent (%) Sodium Chloride (NaCl).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline to Week 4 in Pore Volume in the Cheek Area	Antera 3D will be used as an assessment tool.	Baseline (Day 1), Week 4
Change from Baseline to Week 4 in Sebum Level in the Forehead Area	Sebumeter will be used as an assessment tool.	Baseline (Day 1), Week 4

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cheek pore size assessed as "large" by the investigator
Oily skin on the forehead

Exclusion Criteria:

Treatment with Botulinum toxin (BoNT) of any serotype in the face within the last 12 months
Facial cosmetic procedure (e.g., chemical peel, photo rejuvenation, mesotherapy, photodynamic therapy, laser treatment, ultrasound treatment, tattooing of eyebrows) within the last 12 months
Treatment with any dermal filler in the face within the last 12 months
Any previous insertion of permanent material in the face, including permanent dermal fillers (e.g., silicone, polymethyl methacrylate)
Any medical condition that may put the subject at increased risk with exposure to botulinum toxin of any serotype

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Merz Medical Expert	Merz North America, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Merz Investigation Site #0010473		Los Angeles	California	90017	United States
Merz Investigation Site #0010101

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

Intervention Browse Module

MeSH Terms

ID	Term
C545476	incobotulinumtoxinA

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided