Clinical trial NCT05585398: A Study to Evaluate the Distribution of Botulinum Neurotoxin Type A Administered as Intradermal Injections, Comparing Different Doses, Concentrations, and Delivery Methods
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: N/A, as no Specific Medical Condition Will be Treated
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2022-10-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Intra-individual comparison
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
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
timeFrame: Week 4
Secondary outcomes:
measure: 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
timeFrame: Week 4
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Merz Investigational Site #0490385
Study officials:
affiliation: Merz Therapeutics GmbH
name: Merz Medical Expert
role: STUDY_DIRECTOR
References: