Topical Therapy With Cooling Effect in Dry Itchy Skin

February 1, 2010 updated by: University Hospital Muenster

kühlender Effekt Der Eucerin pH5 Lotion Und Der Eucerin pH5 Lotion Mit Cooling Compound Bei Trockener, Juckender Haut

Dry skin is a physiological condition and is characterized in contrast to greasy skin by roughness, desquamation and lack of brightness of the skin surface. Subjectively, feelings of tension, burning and itching can occur. The skin reacts more intensive on external and physical noxae. Dry skin is caused by a lack of moisture. This is most common during the winter months, when heating systems dry the air. Bathing with hot water, spending extended periods of time in the hot sun, and the skin's natural aging process also remove moisture and oils from the skin. It is diagnosed through clinical observation. People suffering from dry skin often desire to improve this condition for optical cosmetic reasons and due to the occasional feeling of tension. The aim of this investigation is to observe the improvement (or not) of dry itchy skin by a lotion containing a cooling compound

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The patient use the lotion twice daily for a four-week period. Additionally, the patient receives a documentation sheets to note several parameters. In a sensory assessment, product specific parameter such as spreadability, permeability, lubricating, smell of lotion and cosmetic acceptance during the treatment will be assessed (at the beginning, after 2 weeks, after 4 weeks, 2 weeks after stopping treatment). Before and after skin care measurement, the skin surface will be investigated by d-squames and corneometer. After four weeks the skin care measurement will be terminated and the patient can continue with a treatment of his choice. A monitoring of at least 70 patients is intended.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

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
      • Münster, Germany, 48149
        • Department of Dermatology, University of Münster

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients age: over 18 years
  2. itch over VAS 3

Exclusion Criteria:

  1. pregnancy, lactating women
  2. drug abuse
  3. active psychosomatic and psychiatric disease
  4. active cancer.
  5. topical application of tacrolimus, pimecrolimus, corticosteroids or capsaicin two weeks before study start
  6. intake of antihistamines, corticosteroids, cyclosporine A and other immunosuppressants, naltrexone, UV-therapy two weeks before study start
  7. participation in any other research study during the previous 4 weeks.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
ph5 Eucerin Lotion with cooling compound
Device: cooling compound (ph5 Eucerin)
application twice daily to the skin
Other Names:
  • ph5 Eucerin
Placebo Comparator: 2
ph5 Eucerin Lotion
Device: cooling compound (ph5 Eucerin)
application twice daily to the skin
Other Names:
  • ph5 Eucerin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compensate the roughness of the skin Compensate sensory symptoms
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

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

Sponsor

University Hospital Muenster

Investigators

  • Principal Investigator: Sonja Ständer, MD, Department of Dermatology, University of Münster

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

April 22, 2008

First Submitted That Met QC Criteria

April 29, 2008

First Posted (Estimate)

April 30, 2008

Study Record Updates

Last Update Posted (Estimate)

February 2, 2010

Last Update Submitted That Met QC Criteria

February 1, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SST-Pr-12-2007
  • 2007-510-f-S

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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