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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05784363
Other study ID # M602011077
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date October 27, 2022
Est. completion date August 2024

Study information

Verified date June 2024
Source Merz North America, Inc.
Contact n/a
Is FDA regulated No
Health authority
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 Active, not recruiting
Enrollment 31
Est. completion date August 2024
Est. primary completion date June 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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT05097157 - Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions N/A
Completed NCT05254210 - Feasibility Study To Collect Safety And Preliminary Efficacy Data For A Radiofrequency Microneedling Device N/A
Recruiting NCT04471948 - The Safety and Efficacy of 1064-nm Picosecond Laser With Microlens Array for Pore Tightening; a Pilot Study N/A
Active, not recruiting NCT02544958 - Er:YAG Laser for Treatment of Enlarged Pores N/A
Recruiting NCT05987319 - Feasibility Study to Collect and Assess Safety Data for a Radiofrequency Microneedling Device for Electrocoagulation and Hemostasis of Soft Tissues for Dermatologic Conditions N/A
Active, not recruiting NCT06293755 - Microneedle Patch With Botulinum Toxin in Management of Enlarged Facial Pores Phase 3