A Study of NT 201 in the Treatment of Enlarged Pores and Excessive Sebum Production in the Face (LESS)

April 23, 2024 updated by: Merz North America, Inc.

A Prospective, Randomized, Double-blind, Placebo-controlled, Multi-center Exploratory Study to Investigate NT 201 in the Treatment of Enlarged Pores and Excessive Sebum Production in the Face

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90017
        • Recruiting
        • Merz Investigation Site #0010473
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Recruiting
        • Merz Investigation Site #0010101
    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • Recruiting
        • Merz Investigation Site #001097

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NT 201
Single NT 201 injection treatment.
Drug: NT 201
Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9 percent (%) Sodium Chloride (NaCl).
Other Names:
  • IncobotulinumtoxinA
  • Xeomin Cosmetic
  • Xeomeen
  • Xeomin/Bocouture®
Placebo Comparator: Placebo
Single placebo injection treatment.
Drug: Placebo
Solution for injection prepared by reconstitution of powder with 0.9% NaCl.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline to Week 4 in Pore Volume in the Cheek Area
Time Frame: Baseline (Day 1), Week 4
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
Time Frame: Baseline (Day 1), Week 4
Sebumeter will be used as an assessment tool.
Baseline (Day 1), Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merz North America, Inc.

Investigators

  • Study Director: Merz Medical Expert, Merz North America, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M602011077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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