Clinical trial NCT00669708: Topical Therapy With Cooling Effect in Dry Itchy Skin
Official title: kühlender Effekt Der Eucerin pH5 Lotion Und Der Eucerin pH5 Lotion Mit Cooling Compound Bei Trockener, Juckender Haut
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Compensate the Roughness of the Skin
Compensate the Sensory Symptoms
Keywords: dry skin
cooling
itch
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2008-04-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 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.

Primary outcomes:
measure: Compensate the roughness of the skin Compensate sensory symptoms
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Department of Dermatology, University of Münster
Study officials:
affiliation: Department of Dermatology, University of Münster
name: Sonja Ständer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.