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NT 201 for Oily Skin (LESS Trial)

Phase 1
Recruiting
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
Awards & highlights

LESS Trial Summary

This trial tests injecting NT 201 to reduce enlarged pores and oily skin on the face, to see if it's safe and effective.

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.Check my eligibility
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.See study design
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.

LESS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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)

LESS 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
~1380

Find a Location

Who is running the clinical trial?

Merz North America, Inc.Lead Sponsor
63 Previous Clinical Trials
8,772 Total Patients Enrolled
Merz Medical ExpertStudy DirectorMerz North America, Inc.
38 Previous Clinical Trials
7,077 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants of this trial required to be over 18 years old?

"Per the criteria for involvement in this research, individuals must be in between 21 and 39 years of age."

Answered by AI

To what extent could exposure to NT 201 cause harm?

"Due to the preliminary stage of research, NT 201 has been assigned a safety rating of 1. Little evidence exists regarding its efficacy and safety profile."

Answered by AI

Am I a viable candidate for participating in this medical experiment?

"To be accepted into this research, applicants must present enlarged pores and fall within the 21 to 39 year old range. The trial's target recruitment is 30 participants."

Answered by AI

Are there any openings for participants in this clinical experiment at the moment?

"Affirmative. The information posted on clinicaltrials.gov demonstrates that this medical study is actively enlisting patients; the trial was initially unveiled on October 27th 2022 and has been recently revised as of March 13th 2023. A total of 30 participants are needed from one location."

Answered by AI

How many individuals are currently enrolling in this trial experiment?

"Yes, the data available on clinicaltrials.gov confirms that this research trial is presently seeking participants. Initially published on October 27th 2022, it was most recently amended on March 13th 2023 and requires 30 patients from 1 medical centre to take part in the study."

Answered by AI

Who else is applying?

What site did they apply to?
Merz Investigation Site #0010473
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of NT 201 in the Treatment of Enlarged Pores and Excessive Sebum Production in the Face
2022. "A Study of NT 201 in the Treatment of Enlarged Pores and Excessive Sebum Production in the Face". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05784363.
~8 spots leftby Dec 2024
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