A Study of NT 201 in the Treatment of Enlarged Pores and Excessive Sebum Production in the Face
LESS
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
1 other identifier
interventional
31
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2022
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 27, 2022
CompletedFirst Submitted
Initial submission to the registry
March 13, 2023
CompletedFirst Posted
Study publicly available on registry
March 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 17, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2024
CompletedAugust 23, 2024
August 1, 2024
1.6 years
March 13, 2023
August 21, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
NT 201
EXPERIMENTALSingle NT 201 injection treatment.
Placebo
PLACEBO COMPARATORSingle placebo injection treatment.
Interventions
Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9 percent (%) Sodium Chloride (NaCl).
Eligibility Criteria
You may qualify if:
- Cheek pore size assessed as "large" by the investigator
- Oily skin on the forehead
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Merz Investigation Site #0010473
Los Angeles, California, 90017, United States
Merz Investigation Site #0010101
Coral Gables, Florida, 33146, United States
Merz Investigation Site #001097
Nashville, Tennessee, 37215, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Merz Medical Expert
Merz North America, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2023
First Posted
March 24, 2023
Study Start
October 27, 2022
Primary Completion
June 17, 2024
Study Completion
July 31, 2024
Last Updated
August 23, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share