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

This study has been completed.
Sponsor:
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00663364
First received: April 14, 2008
Last updated: July 6, 2010
Last verified: February 2009
  Purpose

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.


Condition Intervention
Eczema
Drug: Physiogel AI Lotion, Physiogel Lotion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Klinische Untersuchung Zur Pflege Trockener Haut Mit Physiogel AI Lotion Und Physiogel Lotion

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • Improvement of dry skin Improvement of burning, stinging and pruritus (if present) Improvement of quality of life [ Time Frame: two weeks ] [ Designated as safety issue: No ]
  • Improvement of burning, stinging and pruritus (if present) [ Time Frame: two weeks ] [ Designated as safety issue: No ]
  • Improvement of quality of life [ Time Frame: two weeks ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: April 2008
Study Completion Date: November 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663364

Locations
Germany
Department of Dermatology
Münster, NRW, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
Investigators
Principal Investigator: Sonja Ständer, MD Department of Dermatology, University Hopsital Münster
  More Information

Additional Information:
No publications provided

Responsible Party: Sonja Ständer, Prof. Dr., Department of Dermatology, University of Münster
ClinicalTrials.gov Identifier: NCT00663364     History of Changes
Other Study ID Numbers: SST-Pr-5-2006
Study First Received: April 14, 2008
Last Updated: July 6, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:
dry skin

Additional relevant MeSH terms:
Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous

ClinicalTrials.gov processed this record on April 15, 2014