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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05784363

Acronym

LESS

Enrollment

Registered

2023-03-24

Start date

2022-10-27

Completion date

2024-07-31

Last updated

2024-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enlarged Pores, Sebum Production

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.

Interventions

DRUGNT 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).

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026