Enlarged PoresPhase 1LESSNCT05784363
A Study of NT 201 in the Treatment of Enlarged Pores and Excessive Sebum Production in the Face
A Phase 1 study testing NT 201 in people with Enlarged Pores and Sebum Production, run by Merz North America, Inc. at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Enlarged Pores, Sebum Production
- What is being tested?
- NT 201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Oct 2022to 31 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Cheek pore size assessed as "large" by the investigator
- Oily skin on the forehead
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Merz Investigation Site #0010101
Coral Gables, Florida, 33146
Merz Investigation Site #0010473
Los Angeles, California, 90017
Merz Investigation Site #001097
Nashville, Tennessee, 37215
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Enlarged Pores, Sebum Production
- Being tested
- NT 201, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT 201Drug
Also called IncobotulinumtoxinA, Xeomin/Bocouture®, Xeomin Cosmetic, Xeomeen
Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9 percent (%) Sodium Chloride (NaCl).
PlaceboDrug
Solution for injection prepared by reconstitution of powder with 0.9% NaCl.
| Study group | Role | What they receive |
|---|---|---|
| NT 201 | Experimental | Single NT 201 injection treatment. Receives: Drug: NT 201 |
| Placebo | Placebo comparator | Single placebo injection treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Week 4 in Pore Volume in the Cheek Area
Antera 3D will be used as an assessment tool.
Measured: 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.
Measured: Baseline (Day 1), Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start27 Oct 2022
- Primary completion17 Jun 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enlarged PoresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, Merz North America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784363
- Sponsor's protocol ID
- M602011077
- Acronym
- LESS
- Status last verified
- Aug 2024
- First submitted
- 13 Mar 2023
- Last updated
- 23 Aug 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05784363
- Acronym / sponsor ID
- LESS / M602011077
- Conditions
- Enlarged Pores, Sebum Production
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NT 201 | Experimental | Drug: NT 201Single NT 201 injection treatment. |
| Placebo | Placebo comparator | Drug: PlaceboSingle placebo injection treatment. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Cheek pore size assessed as "large" by the investigator
- Oily skin on the forehead
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NT 201Also: IncobotulinumtoxinA, Xeomin/Bocouture®, Xeomin Cosmetic, XeomeenClostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9 percent (%) Sodium Chloride (NaCl). | Drug | NT 201 |
| PlaceboSolution for injection prepared by reconstitution of powder with 0.9% NaCl. | Drug | Placebo |
Primary outcome
Change from Baseline to Week 4 in Pore Volume in the Cheek Area
Time frame: 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
Time frame: Baseline (Day 1), Week 4
Sebumeter will be used as an assessment tool.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merz Medical Expert study director
Merz North America, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NT 201 in people with Enlarged Pores and Sebum Production, run by Merz North America, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to Week 4 in Pore Volume in the Cheek Area (time frame: Baseline (Day 1), Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.