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

University Hospital Muenster

Status: Completed

Conditions: Eczema

Treatments: Drug: Physiogel AI Lotion, Physiogel Lotion

Study type: Interventional

Funder types: Other

Identifiers

NCT00663364

SST-Pr-5-2006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

I

Active Comparator group

Description:

Physiogel AI Lotion

Treatment:

Drug: Physiogel AI Lotion, Physiogel Lotion

II

Active Comparator group

Description:

Physiogel Lotion twice daily

Treatment:

Drug: Physiogel AI Lotion, Physiogel Lotion