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

NCT00663364 | Completed DMC

• 1 other identifier: SST-Pr-5-2006
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Eczema

Keywords

dry skin

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

I

ACTIVE COMPARATOR

Physiogel AI Lotion

Drug: Physiogel AI Lotion, Physiogel Lotion

II

ACTIVE COMPARATOR

Physiogel Lotion twice daily

Drug: Physiogel AI Lotion, Physiogel Lotion

Interventions

Physiogel AI Lotion, Physiogel Lotion DRUG

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

I; II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

Department of Dermatology

Münster, North Rhine-Westphalia, 48149, Germany

Location

MeSH Terms

Conditions

Eczema

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Sonja Ständer, MD

  Department of Dermatology, University Hopsital Münster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 14, 2008
• First Posted: April 22, 2008
• Study Start: April 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: November 1, 2009
• Last Updated: July 7, 2010

Record last verified: 2009-02

Locations

DE (1)