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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-27

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Enlarged Pores Sebum Production

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NT 201

Single NT 201 injection treatment.

Group Type EXPERIMENTAL

NT 201

Intervention Type DRUG

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

Single placebo injection treatment.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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).

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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IncobotulinumtoxinA Xeomin/Bocouture® Xeomin Cosmetic Xeomeen

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No