Kinetics of Etheric Oils, Smart Textiles vs. Ointment - Full Text View

Sponsored by:	Dresden University of Technology
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00299559

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 I

MedlinePlus related topics: Common Cold

Drug Information available for: Menthol Camphor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment
Official Title:	An Open Clinical Cross-Over Trial to Compare the Kinetics of Etheric Oils Applied Onto the Skin or Via Smart Textiles

Further study details as provided by Dresden University of Technology:

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 ]

Secondary Outcome Measures:

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

Enrollment:	6
Study Start Date:	March 2006
Study Completion Date:	August 2006

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

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

Dresden University of Technology

Investigators

Principal Investigator:

Joachim Siegert, MDDPharm,PhD

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

More Information

Study ID Numbers:	EK222122005
Study First Received:	March 3, 2006
Last Updated:	November 20, 2007
ClinicalTrials.gov Identifier:	NCT00299559
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:

common cold
organic chemicals
menthol
cineole

camphor
etheric oils
alternative medicine
smart textiles

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Common Cold

Cineole
Camphor
Picornaviridae Infections
Menthol

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Infective Agents, Local
RNA Virus Infections
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009