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Topical Therapy With Cooling Effect in Dry Itchy Skin

U

University Hospital Muenster

Status

Completed

Conditions

Compensate the Sensory Symptoms
Compensate the Roughness of the Skin

Treatments

Device: cooling compound (ph5 Eucerin)

Study type

Interventional

Funder types

Other

Identifiers

NCT00669708
SST-Pr-12-2007
2007-510-f-S

Details and patient eligibility

About

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

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

70 participants in 2 patient groups, including a placebo group

1
Active Comparator group
Description:
ph5 Eucerin Lotion with cooling compound
Treatment:
Device: cooling compound (ph5 Eucerin)
2
Placebo Comparator group
Description:
ph5 Eucerin Lotion
Treatment:
Device: cooling compound (ph5 Eucerin)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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