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

Merz Pharmaceuticals

Status and phase: Completed; Phase 1

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

Treatments: Drug: IncobotulinumtoxinA

Study type: Interventional

Funder types: Industry

Identifiers

NCT05585398

M602011074

2021-005901-29 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

LMRC (left with micro-/right with conv- needle)

Experimental group

Treatment:

Drug: IncobotulinumtoxinA

RMLC (right with micro-/left with conv- needle)

Experimental group

Treatment:

Drug: IncobotulinumtoxinA

LCRM (left with conv-/ right with micro-needles)

Experimental group

Treatment:

Drug: IncobotulinumtoxinA

RCLM (right with conv-/left with micro-needles)

Experimental group

Treatment:

Drug: IncobotulinumtoxinA