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

April 22, 2008
April 30, 2008
February 2, 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 ]
Same as current
Complete list of historical versions of study NCT00669708 on Archive Site
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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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Ständer S, Augustin M, Roggenkamp D, Blome C, Heitkemper T, Worthmann AC, Neufang G. Novel TRPM8 agonist cooling compound against chronic itch: results from a randomized, double-blind, controlled, pilot study in dry skin. J Eur Acad Dermatol Venereol. 2017 Jun;31(6):1064-1068. doi: 10.1111/jdv.14041. Epub 2016 Dec 7.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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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