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Care of the Dry Skin With Physiogel AI Lotion® (W0156)

Primary Purpose

Eczema

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Physiogel AI Lotion, Physiogel Lotion

About this trial

This is an interventional supportive care trial for Eczema focused on measuring dry skin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients age: over 18 years
Willing to apply skin care for 2 to 4 weeks, twice daily
Willing to fulfill questionnaires / home diaries: self-perception of roughness of the skin, desquamation of the skin, lack of skin brightness, feelings of tension and itching

Exclusion Criteria:

Participation in any other research study during the previous 4 weeks.
Previous participation in this study.
Concurrent participation in any other research study involving an investigational product.
Current need for the use of topical steroids.
History of skin disease or allergy likely to interfere with the study or known sensitivity to the test product or its ingredients.
Subjects considered unable or unlikely to fulfill diaries.
Employees of (CRO) or Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings or sibling's offspring) of an employee.
History of cancer.
Recent immunization (less than 10 days prior to the use of the test product).

Sites / Locations

Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Physiogel AI Lotion

Physiogel Lotion twice daily

Outcomes

Primary Outcome Measures

Improvement of dry skin Improvement of burning, stinging and pruritus (if present) Improvement of quality of life

Improvement of burning, stinging and pruritus (if present)

Improvement of quality of life

Secondary Outcome Measures

Full Information

NCT ID

NCT00663364

First Posted

April 14, 2008

Last Updated

July 6, 2010

Sponsor

University Hospital Muenster

1. Study Identification

Unique Protocol Identification Number

NCT00663364

Brief Title

Care of the Dry Skin With Physiogel AI Lotion® (W0156)

Official Title

Klinische Untersuchung Zur Pflege Trockener Haut Mit Physiogel AI Lotion Und Physiogel Lotion

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital Muenster

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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. Dry skin needs special care due to its structural and functional characteristics.We monitor an application test the Dermatocosmetics Oilatum Physiogel AI Lotion and Physiogel Lotion. This is to be accomplished with patients having dry skin. The influence on the roughness of skin, desquamation, feeling of tingle, burning and itching should be documented. If sleep quality is disturbed by tingle or itch, this will be monitored, too.

Detailed Description

The included patients use the lotion twice daily for a two-week period. If not sufficient it can be continued up to a four-weeks 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). 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 50 patients per preparation is intended.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eczema

Keywords

dry skin

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Physiogel AI Lotion

Arm Title

Arm Type

Active Comparator

Arm Description

Physiogel Lotion twice daily

Intervention Type

Drug

Intervention Name(s)

Physiogel AI Lotion, Physiogel Lotion

Intervention Description

Physiogel AI Lotion and Physiogel Lotion is a cosmetic, applied twice daily to dry skin

Primary Outcome Measure Information:

Title

Improvement of dry skin Improvement of burning, stinging and pruritus (if present) Improvement of quality of life

Time Frame

two weeks

Title

Improvement of burning, stinging and pruritus (if present)

Time Frame

two weeks

Title

Improvement of quality of life

Time Frame

two weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients age: over 18 years Willing to apply skin care for 2 to 4 weeks, twice daily Willing to fulfill questionnaires / home diaries: self-perception of roughness of the skin, desquamation of the skin, lack of skin brightness, feelings of tension and itching Exclusion Criteria: Participation in any other research study during the previous 4 weeks. Previous participation in this study. Concurrent participation in any other research study involving an investigational product. Current need for the use of topical steroids. History of skin disease or allergy likely to interfere with the study or known sensitivity to the test product or its ingredients. Subjects considered unable or unlikely to fulfill diaries. Employees of (CRO) or Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings or sibling's offspring) of an employee. History of cancer. Recent immunization (less than 10 days prior to the use of the test product).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sonja Ständer, MD

Organizational Affiliation

Department of Dermatology, University Hopsital Münster

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Dermatology

City

Münster

State/Province

NRW

ZIP/Postal Code

48149

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Care of the Dry Skin With Physiogel AI Lotion® (W0156)

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