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CompletedNCT00669708Updated Feb 2, 2010

Topical Therapy With Cooling Effect in Dry Itchy Skin

An interventional study of cooling compound (ph5 Eucerin) in Compensate the Roughness of the Skin and Compensate the Sensory Symptoms, sponsored by University Hospital Muenster. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-02-02.

Sponsored by University Hospital Muenster · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Compensate the Roughness of the Skin
  • Compensate the Sensory Symptoms

Keywords

  • dry skin
  • cooling
  • itch
03

In context

Lead sponsor

University Hospital Muenster is the lead sponsor of 189 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
70 participants (estimated)

Study arms

  • Active comparator
    1

    ph5 Eucerin Lotion with cooling compound

    Device: cooling compound (ph5 Eucerin)

  • Placebo comparator
    2

    ph5 Eucerin Lotion

    Device: cooling compound (ph5 Eucerin)

Interventions

  • Devicecooling compound (ph5 Eucerin)

    application twice daily to the skin

    Also known as: ph5 Eucerin

06

What researchers measure

Primary outcomes

  1. Compensate the roughness of the skin Compensate sensory symptoms

    Time frame: 4 weeks

07

Study locations

1 site
  • Department of Dermatology, University of Münster
    Münster, 48149, Germany
08

References and documents

Publications

  • Stander 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. PubMed 27862339 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00669708
Lead sponsor
University Hospital Muenster
First posted
Apr 30, 2008
Start date
Apr 2008
Primary completion
Feb 2010
Completion
Feb 2010
Last update
Feb 2, 2010

Study contacts

Sonja Ständer, MD
principal investigator · Department of Dermatology, University of Münster

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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