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
  Purpose

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 Intervention
Compensate the Roughness of the Skin
Compensate the Sensory Symptoms
Device: cooling compound (ph5 Eucerin)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: kühlender Effekt Der Eucerin pH5 Lotion Und Der Eucerin pH5 Lotion Mit Cooling Compound Bei Trockener, Juckender Haut

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • Compensate the roughness of the skin Compensate sensory symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: April 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669708

Locations
Germany
Department of Dermatology, University of Münster
Münster, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
Investigators
Principal Investigator: Sonja Ständer, MD Department of Dermatology, University of Münster
  More Information

No publications provided

Responsible Party: Prof. Dr. Sonja Ständer, Department of Dermatology
ClinicalTrials.gov Identifier: NCT00669708     History of Changes
Other Study ID Numbers: SST-Pr-12-2007, 2007-510-f-S
Study First Received: April 22, 2008
Last Updated: February 1, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:
dry skin
cooling
itch

ClinicalTrials.gov processed this record on October 19, 2014