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

Last updated: August 21, 2024
Sponsor: Merz North America, Inc.
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

Placebo

NT 201

Clinical Study ID

NCT05784363
M602011077
  • Ages 21-45
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Cheek pore size assessed as "large" by the investigator

  • Oily skin on the forehead

Exclusion

Exclusion Criteria:

  • Treatment with Botulinum toxin (BoNT) of any serotype in the face within the last 12months

  • 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 dermalfillers (e.g., silicone, polymethyl methacrylate)

  • Any medical condition that may put the subject at increased risk with exposure tobotulinum toxin of any serotype

Study Design

Total Participants: 31
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
October 27, 2022
Estimated Completion Date:
July 31, 2024

Study 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.

Connect with a study center

  • Merz Investigation Site #0010473

    Los Angeles, California 90017
    United States

    Site Not Available

  • Merz Investigation Site #0010101

    Coral Gables, Florida 33146
    United States

    Site Not Available

  • Merz Investigation Site #001097

    Nashville, Tennessee 37215
    United States

    Site Not Available

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