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Pain Induced by m-Cresol as Preservative

NCT07600814 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-05-22

No results posted yet for this study

Summary

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.

Conditions

  • Pain
  • Acute Pain
  • Healthy Volunteer Study

Interventions

OTHER

m-Cresol 0.1%

A preservative administered subcutaneously at 0.1%, a common concentration used in medicines.

OTHER

m-Cresol 0.25%

A preservative administered subcutaneously at 0.25%, a common concentration used in medicines.

OTHER

Control Solution

A control solution administered subcutaneously.

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Michael J.M. Fischer · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-25
Primary Completion
2026-06-08
Completion
2026-06-08

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07600814 on ClinicalTrials.gov