A Phase 1 interventional study of NT 201 and Placebo in Enlarged Pores and Sebum Production, sponsored by Merz North America, Inc.. Completed at 3 sites in United States. Open to participants aged 21 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-08-23.
Sponsored by Merz North America, Inc. · Phase 1, Interventional, and Treatment
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.
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.
Merz North America, Inc. is the lead sponsor of 52 studies on the registry; 2 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 18 (95%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single NT 201 injection treatment.
Drug: NT 201
Single placebo injection treatment.
Drug: Placebo
Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9 percent (%) Sodium Chloride (NaCl).
Also known as: IncobotulinumtoxinA, Xeomin/Bocouture®, Xeomin Cosmetic, Xeomeen
Solution for injection prepared by reconstitution of powder with 0.9% NaCl.
Change from Baseline to Week 4 in Pore Volume in the Cheek Area
Antera 3D will be used as an assessment tool.
Time frame: Baseline (Day 1), Week 4
Change from Baseline to Week 4 in Sebum Level in the Forehead Area
Sebumeter will be used as an assessment tool.
Time frame: Baseline (Day 1), Week 4
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Merz North America, Inc.