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

Phase 1

Completed

• Conditions: N/A, as no Specific Medical Condition Will be Treated
• Interventions: Drug: IncobotulinumtoxinA

• Registration Number: NCT05585398
• Lead Sponsor: Merz Pharmaceuticals GmbH

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-14
• Study First Submitted QC: 2022-10-14
• Study First Posted: 2022-10-18
• Study Start: 2022-10-19
• Primary Completion: 2023-02-24
• Study Completion: 2023-04-13
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-21
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LMRC (left with micro-/right with conv- needle)	IncobotulinumtoxinA	-
RMLC (right with micro-/left with conv- needle)	IncobotulinumtoxinA	-
RCLM (right with conv-/left with micro-needles)	IncobotulinumtoxinA	-
LCRM (left with conv-/ right with micro-needles)	IncobotulinumtoxinA	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Merz Investigational Site #0490385; 🇩🇪 Hamburg, Germany