Kinetics of Etheric Oils, Smart Textiles vs. Ointment

Sponsor

Technische Universität Dresden (Other)

Overall Status

Completed

CT.gov ID

NCT00299559

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Common Cold	Drug: smart textiles containing menthol, camphor, cineol	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (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

Study Start Date :

Mar 1, 2006

Actual Primary Completion Date :

Aug 1, 2006

Actual Study Completion Date :

Aug 1, 2006

Arms and Interventions

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

Arm

Intervention/Treatment

Other: 1

cross over application of both specimen

Drug: smart textiles containing menthol, camphor, cineol

application to skin

Outcome Measures

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. [24 h]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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