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Topical Therapy With Cooling Effect in Dry Itchy Skin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00669708
Recruitment Status : Completed
First Posted : April 30, 2008
Last Update Posted : February 2, 2010
Information provided by:
University Hospital Muenster

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Compensate the Roughness of the Skin Compensate the Sensory Symptoms Device: cooling compound (ph5 Eucerin) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: kühlender Effekt Der Eucerin pH5 Lotion Und Der Eucerin pH5 Lotion Mit Cooling Compound Bei Trockener, Juckender Haut
Study Start Date : April 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Arm Intervention/treatment
Active Comparator: 1
ph5 Eucerin Lotion with cooling compound
Device: cooling compound (ph5 Eucerin)
application twice daily to the skin
Other Name: ph5 Eucerin

Placebo Comparator: 2
ph5 Eucerin Lotion
Device: cooling compound (ph5 Eucerin)
application twice daily to the skin
Other Name: ph5 Eucerin

Primary Outcome Measures :
  1. Compensate the roughness of the skin Compensate sensory symptoms [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00669708

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Department of Dermatology, University of Münster
Münster, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
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Principal Investigator: Sonja Ständer, MD Department of Dermatology, University of Münster
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Dr. Sonja Ständer, Department of Dermatology Identifier: NCT00669708    
Other Study ID Numbers: SST-Pr-12-2007
First Posted: April 30, 2008    Key Record Dates
Last Update Posted: February 2, 2010
Last Verified: February 2010
Keywords provided by University Hospital Muenster:
dry skin