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

Sponsor
Merz North America, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05784363
Collaborator
(none)
30
Enrollment
2
Locations
2
Arms
13.1
Anticipated Duration (Months)
15
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: NT 201
  • Drug: Placebo
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Oct 27, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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/Bocouture®
  • Xeomin Cosmetic
  • Xeomeen

    		•
    Placebo Comparator: Placebo

    Single placebo injection treatment.

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

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline to Week 4 in Pore Volume in the Cheek Area [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 [Baseline (Day 1), Week 4]

      Sebumeter will be used as an assessment tool.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Merz Investigation Site #0010473 Los Angeles California United States 90017
    2 Merz Investigation Site #001097 Nashville Tennessee United States 37215

    Sponsors and Collaborators

    • Merz North America, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merz North America, Inc.
    ClinicalTrials.gov Identifier:
    NCT05784363
    Other Study ID Numbers:
    • M602011077
    First Posted:
    Mar 24, 2023
    Last Update Posted:
    Mar 28, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    incobotulinumtoxinA

    Study Results

    No Results Posted as of Mar 28, 2023