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

NCT05585398 | Completed Phase 1

• 2 other identifiers: M6020110742021-005901-29
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 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

  Week 4

Study Arms (4)

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

Interventions

IncobotulinumtoxinA DRUG

Intradermal injections using different delivery methods (conventional needle and microneedles)

Also known as: Xeomin, Botulinum toxin type A (150 kiloDalton), free from complexing proteins

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)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merz Pharmaceuticals GmbH: lead

Study Sites (1)

Merz Investigational Site #0490385

Hamburg, 20095, Germany

Location

MeSH Terms

Interventions

incobotulinumtoxinA; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Merz Medical Expert

  Merz Therapeutics GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intra-individual comparison

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 18, 2022
• Study Start: October 19, 2022
• Primary Completion: February 24, 2023
• Study Completion: April 13, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)