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Completed

NCT Number: NCT05784363

A Study of 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.

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Key information

Conditions

Enlarged Pores Sebum Production

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Merz Investigation Site #0010473, Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: IncobotulinumtoxinA, Xeomin/Bocouture®, Xeomin Cosmetic, Xeomeen

Placebo

Drug

Solution for injection prepared by reconstitution of powder with 0.9% NaCl.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Merz North America, Inc.

Industry

Registry information

Official study title

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

Acronym: LESS

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 24, 2023
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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