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

Eczema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00663364
• Other study ID #: SST-Pr-5-2006
• Status: Completed
• Phase: N/A
• First received: April 14, 2008
• Last updated: July 6, 2010
• Start date: April 2008
• Est. completion date: November 2009

Study information

• Verified date: February 2009
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients age: over 18 years

2. Willing to apply skin care for 2 to 4 weeks, twice daily

3. 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:

1. Participation in any other research study during the previous 4 weeks.

2. Previous participation in this study.

3. Concurrent participation in any other research study involving an investigational product.

4. Current need for the use of topical steroids.

5. History of skin disease or allergy likely to interfere with the study or known sensitivity to the test product or its ingredients.

6. Subjects considered unable or unlikely to fulfill diaries.

7. Employees of (CRO) or Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings or sibling's offspring) of an employee.

8. History of cancer.

9. Recent immunization (less than 10 days prior to the use of the test product).

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Eczema

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Dermatology	Münster	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of dry skin Improvement of burning, stinging and pruritus (if present) Improvement of quality of life		two weeks	No
Primary	Improvement of burning, stinging and pruritus (if present)		two weeks	No
Primary	Improvement of quality of life		two weeks	No

External Links

•   Department of Dermatology, University Hospital Münster