A Study to Evaluate the Distribution of Botulinum Neurotoxin Type A Administered as Intradermal Injections, Comparing Different Doses, Concentrations, and Delivery Methods
NCT05585398 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2023-06-22
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
Interventions
- DRUG
-
IncobotulinumtoxinA
Intradermal injections using different delivery methods (conventional needle and microneedles)
Sponsors & Collaborators
-
Merz Pharmaceuticals GmbH
lead INDUSTRY
Principal Investigators
-
Merz Medical Expert · Merz Therapeutics GmbH
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-10-19
- Primary Completion
- 2023-02-24
- Completion
- 2023-04-13
Countries
- Germany
Study Locations
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