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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Eczema

Intervention / Treatment
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* Drug: Physiogel AI Lotion, Physiogel Lotion


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: I<br>Physiogel AI Lotion | Drug: Physiogel AI Lotion, Physiogel Lotion<br>* Physiogel AI Lotion and Physiogel Lotion is a cosmetic, applied twice daily to dry skin<br>|
| Active Comparator: II<br>Physiogel Lotion twice daily | Drug: Physiogel AI Lotion, Physiogel Lotion<br>* Physiogel AI Lotion and Physiogel Lotion is a cosmetic, applied twice daily to dry skin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of dry skin Improvement of burning, stinging and pruritus (if present) Improvement of quality of life |  | two weeks | 
| Improvement of burning, stinging and pruritus (if present) |  | two weeks | 
| Improvement of quality of life |  | two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry skin