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NCT Number: NCT00299559

Kinetics of Etheric Oils, Smart Textiles vs. Ointment

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.

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Key information

Conditions

Common Cold Infections Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Dresden, 01307, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

smart textiles containing menthol, camphor, cineol

Drug

application to skin

Primary outcomes

  1. Determination of agents concentration in exhaled air on study day 1+2. On each day 9 samples of exhaled air will be obtained.

    Time frame: 24 h

Secondary outcomes

  1. Grade of convenience of each application form will obtained at the end of each study day

    Time frame: 48 h

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

An Open Clinical Cross-Over Trial to Compare the Kinetics of Etheric Oils Applied Onto the Skin or Via Smart Textiles

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Mar 7, 2006
Registry last updated
Feb 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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