Kinetics of Etheric Oils, Smart Textiles vs. Ointment

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine whether the application form of etheric oils (camphor, cineol and menthol) causes changes in the concentration of this agents in the exhaled air. The second aim of the study is to determine differences in the subjective convenience of the application forms. We will test an commercial ointment application vs. smart textiles. Smart textiles are new high-tech products with the unique possibility to combine the textiles with functional products e.g. pharmaceutical agents.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Technische Universität Dresden
• Treatments: Camphor; Menthol

Criteria

Inclusion Criteria:

• caucasian

• Broca-index: between -20 and +25%

• who are willing and capable to confirm written consent to enrolment after ample information has been provided

• who are in a stable condition that it can be expected that no changes in relevant medical conditions will occur during the study.

Exclusion Criteria:

• subjects with any major relevant clinical abnormality (as based on extensive medical history, physical examination, vital signs)

• subjects with any major clinically relevant laboratory abnormality.

• subjects who participated in another trial with any investigational substance within the last 4 weeks

• subjects who smoke more than 15 cigarettes per day

• subjects who are known or suspected to be (social) drug dependent, incl. those drinking more than moderately and who are not willing to abstain from alcohol during the active study phase

• subjects who adhere to a diet or lifestyle (incl. competitive sports and weight lifting) that might interfere with the investigation

• subjects who are known or suspected not to comply with the study directives and/or who are known or suspected not to be reliable or trustworthy

• subjects who are known or suspected not to be capable of understanding and evaluating the information that is given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed