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Completed

NCT Number: NCT00663364

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Dermatology

Münster, North Rhine-Westphalia, 48149, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Physiogel AI Lotion, Physiogel Lotion

Drug

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

Primary outcomes

  1. Improvement of dry skin Improvement of burning, stinging and pruritus (if present) Improvement of quality of life

    Time frame: two weeks

  2. Improvement of burning, stinging and pruritus (if present)

    Time frame: two weeks

  3. Improvement of quality of life

    Time frame: two weeks

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 22, 2008
Registry last updated
Jul 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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