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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-19

Study Completion Date

2023-04-13

Brief Summary

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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).

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Intra-individual comparison

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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

Intervention Type DRUG

Other Intervention Names

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Xeomin Botulinum toxin type A (150 kiloDalton), free from complexing proteins

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes