N/A, as no Specific Medical Condition Will be TreatedPhase 1NCT05585398
A Study to Evaluate the Distribution of Botulinum Neurotoxin Type A Administered as Intradermal Injections, Comparing Different Doses, Concentrations, and Delivery Methods
A Phase 1 study testing IncobotulinumtoxinA in people with N/A, as no Specific Medical Condition Will be Treated, run by Merz Pharmaceuticals GmbH at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the distribution of IncobotulinumtoxinA (Xeomin) in healthy subjects at different volumes, concentrations and doses when administered intradermally and subcutaneously using different delivery methods (conventional needle and microneedles). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- N/A, as no Specific Medical Condition Will be Treated
- What is being tested?
- IncobotulinumtoxinA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 19 Oct 2022to 13 Apr 2023
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subject aged 18 to 45 years with body mass index (BMI) 19.0 to 27.0 kg/m².
- Subject with the distance not less than 45 cm between the spinous process of the 7th cervical vertebra (C7) and the 4th lumbar vertebra (L4).
- Healthy skin at test area (forehead and back).
- Fitzpatrick skin type I to IV.
- Displaying uniform sweating activity (i.e., symmetrical sweating pattern with enough sweat and without anhidrotic regions) on the forehead area as assessed with Minor's starch iodine test under standardized sweating conditions.
Who cannot join
- Any chronic pain conditions or presence of acute pain of any origin and intensity.
- Dermal treatment of the forehead (e.g., light resurfacing, dermabrasions) within the last 12 months before Screening, during the screening period, and/or at Baseline.
- Any type of filler in the treatment area on the facial region within the last 12 months before Screening, during the screening period, and/or atBaseline; regardless of time for any type of implant and/or surgery in the treatment area on facial region.
- Any type of surgery in the treatment area of the back within the last 12 months before Screening, during the screening period, and/or at Baseline.
- Treatment with anticholinergics within the last 14 days before Screening, during the screening period, and/or at Baseline.
- Treatment with analgesics (e.g., non steroidal anti inflammatory drugs, except acetylsalicylic acid, ibuprofen, and paracetamol) within the last 10 days before Screening, during the screening period, and/or prior to pain assessment at Baseline.
- Treatment with paracetamol, ibuprofen, or acetylsalicylic acid within three days prior to pain assessment at Baseline.
- Subjects with excessive sweating or previously diagnosed with hyperhidrosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Single-center Study to Evaluate the Distribution of NT 201 Administered as Intradermal Injections, Comparing Different Doses, Concentrations, and Delivery Methods
The purpose of this study is to evaluate the distribution of IncobotulinumtoxinA (Xeomin) in healthy subjects at different volumes, concentrations and doses when administered intradermally and subcutaneously using different delivery methods (conventional needle and microneedles).
- 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, Botulinum toxin type A (150 kiloDalton), free from complexing proteins
Intradermal injections using different delivery methods (conventional needle and microneedles)
| Study group | Role | What they receive |
|---|---|---|
| LMRC (left with micro-/right with conv- needle) | Experimental | Not described Receives: Drug: IncobotulinumtoxinA |
| RMLC (right with micro-/left with conv- needle) | Experimental | Not described Receives: Drug: IncobotulinumtoxinA |
| LCRM (left with conv-/ right with micro-needles) | Experimental | Not described Receives: Drug: IncobotulinumtoxinA |
| RCLM (right with conv-/left with micro-needles) | Experimental | Not described Receives: Drug: IncobotulinumtoxinA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area of anhidrosis on contralateral points of the forehead four weeks after intradermal injections of NT 201 with fixed dose and volume, using different delivery methods
Measured: Week 4
Secondary outcomes (1)
Injection pain intensity as assessed by a 0-10 numeric pain rating scale directly after the intradermal injection of NT 201 applied via different delivery methods in the forehead
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start19 Oct 2022
- Primary completion24 Feb 2023
- Study completion13 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for N/A, as no Specific Medical Condition Will be TreatedStudies 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
- Single group
- Model description
- Intra-individual comparison
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, Merz Therapeutics GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585398
- Sponsor's protocol ID
- M602011074
- Other IDs
- 2021-005901-29
- Status last verified
- Jun 2023
- First submitted
- 14 Oct 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Single-center Study to Evaluate the Distribution of NT 201 Administered as Intradermal Injections, Comparing Different Doses, Concentrations, and Delivery Methods
- ClinicalTrials.gov ID
- NCT05585398
- Acronym / sponsor ID
- M602011074
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 24 Feb 2023 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 18 Oct 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.
The purpose of this study is to evaluate the distribution of IncobotulinumtoxinA (Xeomin) in healthy subjects at different volumes, concentrations and doses when administered intradermally and subcutaneously using different delivery methods (conventional needle and microneedles).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Intra-individual comparison
| Arm | Type | Receives |
|---|---|---|
| LMRC (left with micro-/right with conv- needle) | Experimental | Drug: IncobotulinumtoxinA |
| RMLC (right with micro-/left with conv- needle) | Experimental | Drug: IncobotulinumtoxinA |
| LCRM (left with conv-/ right with micro-needles) | Experimental | Drug: IncobotulinumtoxinA |
| RCLM (right with conv-/left with micro-needles) | Experimental | Drug: IncobotulinumtoxinA |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female subject aged 18 to 45 years with body mass index (BMI) 19.0 to 27.0 kg/m².
- Subject with the distance not less than 45 cm between the spinous process of the 7th cervical vertebra (C7) and the 4th lumbar vertebra (L4).
- Healthy skin at test area (forehead and back).
- Fitzpatrick skin type I to IV.
- Displaying uniform sweating activity (i.e., symmetrical sweating pattern with enough sweat and without anhidrotic regions) on the forehead area as assessed with Minor's starch iodine test under standardized sweating conditions.
Key exclusion criteria (8 listed)
- Any chronic pain conditions or presence of acute pain of any origin and intensity.
- Dermal treatment of the forehead (e.g., light resurfacing, dermabrasions) within the last 12 months before Screening, during the screening period, and/or at Baseline.
- Any type of filler in the treatment area on the facial region within the last 12 months before Screening, during the screening period, and/or atBaseline; regardless of time for any type of implant and/or surgery in the treatment area on facial region.
- Any type of surgery in the treatment area of the back within the last 12 months before Screening, during the screening period, and/or at Baseline.
- Treatment with anticholinergics within the last 14 days before Screening, during the screening period, and/or at Baseline.
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, Botulinum toxin type A (150 kiloDalton), free from complexing proteinsIntradermal injections using different delivery methods (conventional needle and microneedles) | Drug | LCRM (left with conv-/ right with micro-needles), LMRC (left with micro-/right with conv- needle), RCLM (right with conv-/left with micro-needles), RMLC (right with micro-/left with conv- needle) |
Primary outcome
Area of anhidrosis on contralateral points of the forehead four weeks after intradermal injections of NT 201 with fixed dose and volume, using different delivery methods
Time frame: Week 4
1 secondary outcome
Injection pain intensity as assessed by a 0-10 numeric pain rating scale directly after the intradermal injection of NT 201 applied via different delivery methods in the forehead
Time frame: Week 4
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 22 Jun 2023.
- 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 Therapeutics GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IncobotulinumtoxinA in people with N/A, as no Specific Medical Condition Will be Treated, run by Merz Pharmaceuticals GmbH at 1 site in Germany.
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 5 inclusion and 8 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 22 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 Germany. 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.
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?
Area of anhidrosis on contralateral points of the forehead four weeks after intradermal injections of NT 201 with fixed dose and volume, using different delivery methods (time frame: Week 4). 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 22 Jun 2023.