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

NCT ID: NCT00663364

Last Updated: 2010-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-11-30

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.

Conditions

Eczema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

I

Physiogel AI Lotion

Group Type: ACTIVE_COMPARATOR

Physiogel AI Lotion, Physiogel Lotion

Intervention Type: DRUG

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

II

Physiogel Lotion twice daily

Group Type: ACTIVE_COMPARATOR

Physiogel AI Lotion, Physiogel Lotion

Intervention Type: DRUG

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

Interventions

Physiogel AI Lotion, Physiogel Lotion

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

Intervention Type: DRUG

Eligibility Criteria

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).

• 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, University of Münster

Principal Investigators

Sonja Ständer, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, University Hopsital Münster

Locations

Department of Dermatology

Münster, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

SST-Pr-5-2006

Identifier Type: -

Identifier Source: org_study_id