Topical Therapy With Cooling Effect in Dry Itchy Skin | NCT00669708

Studies
Topical Therapy With Cooling Effect in Dry Itchy Skin

NCT00669708

Sponsor

University Hospital Muenster

Status

Completed

Last Update Posted

Feb 2, 2010Estimated

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Compensate the Roughness of the Skin
Compensate the Sensory Symptoms

Interventions

cooling compound (ph5 Eucerin)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2007-510-f-S

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Feb 2010Actual

Completion Date

Feb 2010Actual

First Submitted Date

Apr 22, 2008

First Submission Date that Met QC Criteria

Apr 29, 2008

First Posted Date

Apr 30, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2010

Last Update Posted Date

Feb 2, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University Hospital MuensterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	ph5 Eucerin Lotion with cooling compound	Device: cooling compound (ph5 Eucerin)
2	Placebo Comparator	ph5 Eucerin Lotion	Device: cooling compound (ph5 Eucerin)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cooling compound (ph5 Eucerin)	Device	application twice daily to the skin	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Compensate the roughness of the skin Compensate sensory symptoms		4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients age: over 18 years
itch over VAS 3

Exclusion Criteria:

pregnancy, lactating women
drug abuse
active psychosomatic and psychiatric disease
active cancer.
topical application of tacrolimus, pimecrolimus, corticosteroids or capsaicin two weeks before study start
intake of antihistamines, corticosteroids, cyclosporine A and other immunosuppressants, naltrexone, UV-therapy two weeks before study start
participation in any other research study during the previous 4 weeks.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sonja Ständer, MD	Department of Dermatology, University of Münster	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Dermatology, University of Münster		Münster		48149	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27862339	Derived	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.

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012877	Skin Manifestations
D012816	Signs and Symptoms