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NT 201 for Oily Skin (LESS Trial)

Phase 1
Waitlist Available
Research Sponsored by Merz North America, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1), week 4

Summary

This trial is testing NT 201 injections to treat people with large pores and oily skin. The treatment aims to make pores smaller and reduce oil production, improving skin appearance. Participants will receive the NT 201 injection and be monitored for a few months.

Who is the study for?
This trial is for individuals with oily skin on their forehead and large pores on their cheeks. Participants should not have had facial treatments like dermal fillers, botulinum toxin injections, or cosmetic procedures in the past year. Those with conditions that increase risk from botulinum toxins or permanent facial materials are excluded.
What is being tested?
The study tests NT 201 injections against a placebo to see if they can effectively reduce enlarged pores and excessive sebum production on the face. The safety of NT 201 will also be evaluated during this process.
What are the potential side effects?
While specific side effects aren't listed here, similar treatments often cause temporary redness, swelling at injection sites, muscle weakness, or bruising. Rarely more serious side effects related to botulinum toxin exposure may occur.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1), week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1), week 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline to Week 4 in Pore Volume in the Cheek Area
Change from Baseline to Week 4 in Sebum Level in the Forehead Area

Side effects data

From 2019 Phase 3 trial • 256 Patients • NCT02270736
12%
Respiratory tract infection viral
9%
Pharyngitis
9%
Respiratory tract infection
9%
Rhinitis
6%
Viral infection
3%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
OLEX: NT 201 (Age 2 to 5 Years)
Double-blind MP: Placebo (Age 6 to 17 Years)
Double-blind, MP: NT 201 (Age 6 to 17 Years)
Open-label, MP: NT 201 (Age 2 to 5 Years)
OLEX: NT 201 (Age 6 to 17 Years)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NT 201Experimental Treatment1 Intervention
Single NT 201 injection treatment.
Group II: PlaceboPlacebo Group1 Intervention
Single placebo injection treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NT 201
2015
Completed Phase 4
~1500

Find a Location

Who is running the clinical trial?

Merz North America, Inc.Lead Sponsor
65 Previous Clinical Trials
9,502 Total Patients Enrolled
Merz Medical ExpertStudy DirectorMerz North America, Inc.
39 Previous Clinical Trials
6,444 Total Patients Enrolled

Media Library

NT 201 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05784363 — Phase 1
Seborrhea Research Study Groups: NT 201, Placebo
Seborrhea Clinical Trial 2023: NT 201 Highlights & Side Effects. Trial Name: NCT05784363 — Phase 1
NT 201 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05784363 — Phase 1
~10 spots leftby Dec 2025
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