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

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

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.

Study Overview

• Status: Completed
• Conditions: Eczema
• Intervention / Treatment: Drug: Physiogel AI Lotion, Physiogel Lotion

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Münster, NRW, Germany, 48149
      • Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: I; Physiogel AI Lotion	Drug: Physiogel AI Lotion, Physiogel Lotion; Physiogel AI Lotion and Physiogel Lotion is a cosmetic, applied twice daily to dry skin
ACTIVE_COMPARATOR: II; Physiogel Lotion twice daily	Drug: Physiogel AI Lotion, Physiogel Lotion; Physiogel AI Lotion and Physiogel Lotion is a cosmetic, applied twice daily to dry skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Investigators: Principal Investigator: Sonja Ständer, MD, Department of Dermatology, University Hopsital Münster

Publications and helpful links

Helpful Links

• Department of Dermatology, University Hospital Münster

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (ACTUAL): July 1, 2009
• Study Completion (ACTUAL): November 1, 2009

Study Registration Dates

• First Submitted: April 14, 2008
• First Submitted That Met QC Criteria: April 21, 2008
• First Posted (ESTIMATE): April 22, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): July 7, 2010
• Last Update Submitted That Met QC Criteria: July 6, 2010
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: dry skin
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema
• Other Study ID Numbers: SST-Pr-5-2006