Glabellar Frown Lines and Canthal Lines and/or Horizontal Forehead Lines in the Upper FaceNCT05222607
Longitudinal Evaluation and Real-world Evidence of NT201
An observational study of Glabellar Frown Lines and Canthal Lines and/or Horizontal Forehead Lines in the Upper Face, run by Merz North America, Inc. at 1 site in United States.
Trial summary
This study is to collect long-term real-world evidence data from clinics in several countries in order to obtain an improved understanding of the safety and effectiveness of incobotulinumtoxinA in botulinum neurotoxin type A (BoNT-A) treatment naïve participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glabellar Frown Lines and Canthal Lines and/or Horizontal Forehead Lines in the Upper Face
- What is being tested?
- IncobotulinumtoxinA
- Type of treatment
- Injection or infusion
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2023to 18 May 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female participants, 18 years of age or older, seeking treatment with incobotulinumtoxinA for UFL in the North American, Latin American, European, and Asia-Pacific regions.
Who may be able to join
- 18 years of age or older.
- Planning treatment with incobotulinumtoxinA.
Who cannot join
- Any contraindication to treatment with incobotulinumtoxinA or any other neurotoxins.
- Currently pregnant, breastfeeding, or intending to become pregnant during study participation.
- Known hypersensitivity to incobotulinumtoxinA or any of its formulation ingredients.
- Any infection and/or inflammation at the planned injection points.
- Previous treatment with any botulinum toxin products for any aesthetic or therapeutic indications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LONG RUN: LONGitudinal Evaluation and Real-world Evidence of Uniquely Purified incobotulinumtoxinA (Xeomin) in Treatment Naïve Participants
This study is to collect long-term real-world evidence data from clinics in several countries in order to obtain an improved understanding of the safety and effectiveness of incobotulinumtoxinA in botulinum neurotoxin type A (BoNT-A) treatment naïve participants.
- Conditions
- Glabellar Frown Lines and Canthal Lines and/or Horizontal Forehead Lines in the Upper Face
- Being tested
- IncobotulinumtoxinA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IncobotulinumtoxinADrug
Also called XEOMIN®, BOCOUTURE®
IncobotulinumtoxinA injections for aesthetic indications.
| Study group | Role | What they receive |
|---|---|---|
| Facial treatment with incobotulinumtoxinA in treatment naïve participants | Not described Receives: Drug: IncobotulinumtoxinA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of FACE-Q Patient-Perceived Age Visual Analogue Scale mean change
Explore the effectiveness of the incobotulinumtoxinA injections in treatment naïve participants for facial cosmetic procedures during up to 3 years continuous treatment exposure, as measured by assessment of FACE-Q Patient-Perceived Age Visual Analogue Scale mean change from first treatment visit to the 4-to-6 weeks timepoint.
Measured: Up to 3 years
Secondary outcomes (1)
Assessment of FACE-Q Satisfaction with Decision Scale mean change
Explore the effectiveness of the incobotulinumtoxinA injections in treatment naïve participants for facial cosmetic procedures during up to 3 years continuous treatment exposure, as measured by assessment of FACE-Q Satisfaction with Decision Scale mean change from first treatment visit to the 4-to-6 weeks timepoint.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start10 Feb 2023
- Primary completion18 May 2023
- Study completion18 May 2023
Why it stopped: Corporate Management Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glabellar Frown Lines and Canthal Lines and/or Horizontal Forehead Lines in the Upper FaceStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222607
- Sponsor's protocol ID
- M602011076
- Status last verified
- Jun 2023
- First submitted
- 23 Dec 2021
- Last updated
- 7 Jun 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LONG RUN: LONGitudinal Evaluation and Real-world Evidence of Uniquely Purified incobotulinumtoxinA (Xeomin) in Treatment Naïve Participants
- ClinicalTrials.gov ID
- NCT05222607
- Acronym / sponsor ID
- M602011076
- Conditions
- Glabellar Frown Lines and Canthal Lines and/or Horizontal Forehead Lines in the Upper Face
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Corporate Management Decision
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 18 May 2023 (actual)
- Study completion
- 18 May 2023 (actual)
- First posted
- 3 Feb 2022 (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.
This study is to collect long-term real-world evidence data from clinics in several countries in order to obtain an improved understanding of the safety and effectiveness of incobotulinumtoxinA in botulinum neurotoxin type A (BoNT-A) treatment naïve participants.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Facial treatment with incobotulinumtoxinA in treatment naïve participants | – | Drug: IncobotulinumtoxinA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female participants, 18 years of age or older, seeking treatment with incobotulinumtoxinA for UFL in the North American, Latin American, European, and Asia-Pacific regions.
Key inclusion criteria (2 listed)
- 18 years of age or older.
- Planning treatment with incobotulinumtoxinA.
Key exclusion criteria (5 listed)
- Any contraindication to treatment with incobotulinumtoxinA or any other neurotoxins.
- Currently pregnant, breastfeeding, or intending to become pregnant during study participation.
- Known hypersensitivity to incobotulinumtoxinA or any of its formulation ingredients.
- Any infection and/or inflammation at the planned injection points.
- Previous treatment with any botulinum toxin products for any aesthetic or therapeutic indications.
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 |
|---|---|---|
| IncobotulinumtoxinAAlso: XEOMIN®, BOCOUTURE®IncobotulinumtoxinA injections for aesthetic indications. | Drug | Facial treatment with incobotulinumtoxinA in treatment naïve participants |
Primary outcome
Assessment of FACE-Q Patient-Perceived Age Visual Analogue Scale mean change
Time frame: Up to 3 years
Explore the effectiveness of the incobotulinumtoxinA injections in treatment naïve participants for facial cosmetic procedures during up to 3 years continuous treatment exposure, as measured by assessment of FACE-Q Patient-Perceived Age Visual Analogue Scale mean change from first treatment visit to the 4-to-6 weeks timepoint.
1 secondary outcome
Assessment of FACE-Q Satisfaction with Decision Scale mean change
Time frame: Up to 3 years
Results and safety
The study was stopped early (reason given: Corporate Management Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glabellar Frown Lines and Canthal Lines and/or Horizontal Forehead Lines in the Upper Face, run by Merz North America, Inc. at 1 site 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: stopped early, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Corporate Management Decision). Results are not available in the source record.
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?
Assessment of FACE-Q Patient-Perceived Age Visual Analogue Scale mean change (time frame: Up to 3 years). 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 7 Jun 2023.