Topical Therapy With Cooling Effect in Dry Itchy Skin

NCT ID: NCT00669708

Last Updated: 2010-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2010-02-28

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.

Conditions

Compensate the Roughness of the Skin; Compensate the Sensory Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

ph5 Eucerin Lotion with cooling compound

Group Type: ACTIVE_COMPARATOR

cooling compound (ph5 Eucerin)

Intervention Type: DEVICE

application twice daily to the skin

2

ph5 Eucerin Lotion

Group Type: PLACEBO_COMPARATOR

cooling compound (ph5 Eucerin)

Intervention Type: DEVICE

application twice daily to the skin

Interventions

cooling compound (ph5 Eucerin)

application twice daily to the skin

Intervention Type: DEVICE

Other Intervention Names

ph5 Eucerin

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Muenster

OTHER

Sponsor Role: lead

Responsible Party

Department of Dermatology

Principal Investigators

Sonja Ständer, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, University of Münster

Locations

Department of Dermatology, University of Münster

Münster, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 27862339 (View on PubMed)

Other Identifiers

2007-510-f-S

Identifier Type: -

Identifier Source: secondary_id

SST-Pr-12-2007

Identifier Type: -

Identifier Source: org_study_id