A Study to Evaluate the Distribution of Botulinum Neurotoxin Type A Administered as Intradermal Injections, Comparing Different Doses, Concentrations, and Delivery Methods

Study Overview
=================
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).

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

Conditions
-----------------
N/A, as no Specific Medical Condition Will be Treated

Intervention / Treatment
-----------------
* Drug: IncobotulinumtoxinA


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Intra-individual comparison
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LMRC (left with micro-/right with conv- needle)<br> | Drug: IncobotulinumtoxinA<br>* Intradermal injections using different delivery methods (conventional needle and microneedles)<br>* Other names: Botulinum toxin type A (150 kiloDalton), free from complexing proteins;|
| Experimental: RMLC (right with micro-/left with conv- needle)<br> | Drug: IncobotulinumtoxinA<br>* Intradermal injections using different delivery methods (conventional needle and microneedles)<br>* Other names: Botulinum toxin type A (150 kiloDalton), free from complexing proteins;|
| Experimental: LCRM (left with conv-/ right with micro-needles)<br> | Drug: IncobotulinumtoxinA<br>* Intradermal injections using different delivery methods (conventional needle and microneedles)<br>* Other names: Botulinum toxin type A (150 kiloDalton), free from complexing proteins;|
| Experimental: RCLM (right with conv-/left with micro-needles)<br> | Drug: IncobotulinumtoxinA<br>* Intradermal injections using different delivery methods (conventional needle and microneedles)<br>* Other names: Botulinum toxin type A (150 kiloDalton), free from complexing proteins;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Week 4 |