Pain Induced by m-Cresol as Preservative

Sponsor
Medical University of Vienna
Study ID
NCT07600814
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Acute Pain
  • Healthy Volunteer Study
  • Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • m-Cresol 0.1% — OTHER
    A preservative administered subcutaneously at 0.1%, a common concentration used in medicines.
  • m-Cresol 0.25% — OTHER
    A preservative administered subcutaneously at 0.25%, a common concentration used in medicines.
  • Control Solution — OTHER
    A control solution administered subcutaneously.

Study Details

Preservatives such as m-Cresol are essential components in many subcutaneously injected medications, including insulin or human growth hormone, to prevent bacterial growth. However, clinical reports have suggested that these preservatives may cause local discomfort or pain at the injection site, which can negatively impact treatment adherence. While m-Cresol is widely used, its direct contribution to injection-site pain has not yet been investigated in a prospective clinical trial. This study aims to investigate whether subcutaneous injection of m-Cresol at concentrations commonly used in clinical practice (0.1% and 0.25%) cause significantly more pain than a preservative-free control solution. In a randomized, double-blind crossover design, healthy volunteers will receive three separate injections in a belly fold. Participants will rate their pain every 5 seconds until it subsides. The findings will help determine if m-Cresol is a primary source of injection-site pain and could lead to the development of more comfortable drug formulations.

Key Dates

First listed
May 22, 2026
Start date
May 25, 2026
Status verified
May 2026
Primary completion
Jun 8, 2026
Completion
Jun 8, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: m-Cresol 0.1%
    Participants receive a 300 µl subcutaneous injection of m-Cresol at a concentration of 0.1%.
  • Experimental: m-Cresol 0.25%
    Participants receive a 300 µl subcutaneous injection of m-Cresol at a concentration of 0.25%.
  • Placebo Comparator: Control solution
    Participants receive a 300 µl subcutaneous injection of control solution.

Primary Outcome Measure

Area Under the Curve (AUC) of Pain Intensity [ Time Frame: From injection start until pain subsides (approximately 15-60 seconds per injection). ]

Central Contacts

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