Kinetics of Etheric Oils, Smart Textiles vs. Ointment

NCT ID: NCT00299559

Last Updated: 2009-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2006-08-31

Brief 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.

Detailed Description

On the first appointment recruitment investigations will take place. After the person is enrolled to the study, the first determination of substances concentration in exhaled air and the convenience grade of the application form being exposed to will be achieved (study day 1). After a 7 days lasting washout phase on study day 2 newly determination of substances concentration and convenience grade of the other application will be assessed. Each study day will have an approximate duration of 11 h. During this time 9 samples of the persons exhaled air will be collected.

Conditions

Common Cold

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

cross over application of both specimen

Group Type: OTHER

smart textiles containing menthol, camphor, cineol

Intervention Type: DRUG

application to skin

Interventions

smart textiles containing menthol, camphor, cineol

application to skin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Technische Universität Dresden

OTHER

Sponsor Role: lead

Principal Investigators

Joachim Siegert, MDDPharm,PhD

Role: PRINCIPAL_INVESTIGATOR

Department of clinical Pharmacology, Medical Faculty Carl Gustav Carus, University of Technology

Locations

Department of clinical Pharmacology, Medical faculty Carl Gustav Carus, University of Technology Dresden

Dresden, , Germany

Countries

Germany

Other Identifiers

EK222122005

Identifier Type: -

Identifier Source: org_study_id