Kinetics of Etheric Oils, Smart Textiles vs. Ointment

February 12, 2009 updated by: Technische Universität Dresden

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dresden, Germany, 01307
        • Department of clinical Pharmacology, Medical faculty Carl Gustav Carus, University of Technology Dresden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 1
cross over application of both specimen
Drug: smart textiles containing menthol, camphor, cineol
application to skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 h

Secondary Outcome Measures

Outcome Measure
Time Frame
Grade of convenience of each application form will obtained at the end of each study day
Time Frame: 48 h
48 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Investigators

  • Principal Investigator: Joachim Siegert, MDDPharm,PhD, Department of clinical Pharmacology, Medical Faculty Carl Gustav Carus, University of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (ACTUAL)

August 1, 2006

Study Completion (ACTUAL)

August 1, 2006

Study Registration Dates

First Submitted

March 3, 2006

First Submitted That Met QC Criteria

March 3, 2006

First Posted (ESTIMATE)

March 7, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

February 13, 2009

Last Update Submitted That Met QC Criteria

February 12, 2009

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK222122005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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