A Study of NT 201 in the Treatment of Enlarged Pores and Excessive Sebum Production in the Face
- Registration Number
- NCT05784363
- Lead Sponsor
- Merz North America, Inc.
- 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NT 201 NT 201 Single NT 201 injection treatment. Placebo Placebo Single placebo injection treatment.
- Primary Outcome Measures
Name Time Method Change from Baseline to Week 4 in Pore Volume in the Cheek Area Baseline (Day 1), Week 4 Antera 3D will be used as an assessment tool.
Change from Baseline to Week 4 in Sebum Level in the Forehead Area Baseline (Day 1), Week 4 Sebumeter will be used as an assessment tool.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Merz Investigation Site #0010473
🇺🇸Los Angeles, California, United States
Merz Investigation Site #001097
🇺🇸Nashville, Tennessee, United States
Merz Investigation Site #0010101
🇺🇸Coral Gables, Florida, United States