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Topical Therapy With Cooling Effect in Dry Itchy Skin

This study has been completed.
Sponsor:
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00669708
First received: April 22, 2008
Last updated: February 1, 2010
Last verified: February 2010

April 22, 2008
February 1, 2010
April 2008
February 2010   (final data collection date for primary outcome measure)
Compensate the roughness of the skin Compensate sensory symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00669708 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Topical Therapy With Cooling Effect in Dry Itchy Skin
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

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Compensate the Roughness of the Skin
  • Compensate the Sensory Symptoms
Device: cooling compound (ph5 Eucerin)
application twice daily to the skin
Other Name: ph5 Eucerin
  • Active Comparator: 1
    ph5 Eucerin Lotion with cooling compound
    Intervention: Device: cooling compound (ph5 Eucerin)
  • Placebo Comparator: 2
    ph5 Eucerin Lotion
    Intervention: Device: cooling compound (ph5 Eucerin)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
February 2010
February 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00669708
SST-Pr-12-2007, 2007-510-f-S
No
Prof. Dr. Sonja Ständer, Department of Dermatology
University Hospital Muenster
Not Provided
Principal Investigator: Sonja Ständer, MD Department of Dermatology, University of Münster
University Hospital Muenster
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP