Kinetics of Etheric Oils, Smart Textiles vs. Ointment

This study has been completed.
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00299559
First received: March 3, 2006
Last updated: February 12, 2009
Last verified: November 2007
  Purpose

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.


Condition Intervention Phase
Common Cold
Drug: smart textiles containing menthol, camphor, cineol
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Clinical Cross-Over Trial to Compare the Kinetics of Etheric Oils Applied Onto the Skin or Via Smart Textiles

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Grade of convenience of each application form will obtained at the end of each study day [ Time Frame: 48 h ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: March 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
cross over application of both specimen
Drug: smart textiles containing menthol, camphor, cineol
application to skin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299559

Locations
Germany
Department of clinical Pharmacology, Medical faculty Carl Gustav Carus, University of Technology Dresden
Dresden, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Principal Investigator: Joachim Siegert, MDDPharm,PhD Department of clinical Pharmacology, Medical Faculty Carl Gustav Carus, University of Technology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00299559     History of Changes
Other Study ID Numbers: EK222122005
Study First Received: March 3, 2006
Last Updated: February 12, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität Dresden:
common cold
organic chemicals
menthol
cineole
camphor
etheric oils
alternative medicine
smart textiles

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Camphor
Eucalyptol
Menthol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antipruritics
Dermatologic Agents

ClinicalTrials.gov processed this record on August 25, 2014