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

Enlarged Pores Clinical Trial

— LESS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05784363
• Other study ID #: M602011077
• Status: Recruiting
• Phase: Phase 1
• Start date: October 27, 2022
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Merz North America, Inc.
• Contact: Public Disclosure Manager Merz Aesthetics
• Phone: +1 984-301-3095
• Email: Aesthetic.Trials[@]merz.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Enlarged Pores
• Sebum Production

Intervention

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).
• Placebo
Solution for injection prepared by reconstitution of powder with 0.9% NaCl.

Locations

Country	Name	City	State
United States	Merz Investigation Site #0010101	Coral Gables	Florida
United States	Merz Investigation Site #0010473	Los Angeles	California
United States	Merz Investigation Site #001097	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Merz North America, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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