EczemaNCT00663364
Care of the Dry Skin With Physiogel AI Lotion® (W0156)
A study testing Physiogel AI Lotion, Physiogel Lotion in people with Eczema, run by University Hospital Muenster at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eczema
- What is being tested?
- Physiogel AI Lotion, Physiogel Lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2008to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Dermatology
Münster, North Rhine-Westphalia, 48149
About this study
Official title: 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.
Read the 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.
- Conditions
- Eczema
- Being tested
- Physiogel AI Lotion, Physiogel Lotion
- Keywords
- dry skin
- Medical subject headings
- Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiogel AI Lotion, Physiogel LotionDrug
Physiogel AI Lotion and Physiogel Lotion is a cosmetic, applied twice daily to dry skin
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | Physiogel AI Lotion Receives: Drug: Physiogel AI Lotion, Physiogel Lotion |
| II | Active comparator | Physiogel Lotion twice daily Receives: Drug: Physiogel AI Lotion, Physiogel Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of dry skin Improvement of burning, stinging and pruritus (if present) Improvement of quality of life
Measured: two weeks
Improvement of burning, stinging and pruritus (if present)
Measured: two weeks
Improvement of quality of life
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionJul 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Investigators
- Sonja Ständer, MD, Principal investigator, Department of Dermatology, University Hopsital Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663364
- Sponsor's protocol ID
- SST-Pr-5-2006
- Status last verified
- Feb 2009
- First submitted
- 14 Apr 2008
- Last updated
- 7 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Klinische Untersuchung Zur Pflege Trockener Haut Mit Physiogel AI Lotion Und Physiogel Lotion
- ClinicalTrials.gov ID
- NCT00663364
- Acronym / sponsor ID
- SST-Pr-5-2006
- Conditions
- Eczema
- Keywords
- dry skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Drug: Physiogel AI Lotion, Physiogel LotionPhysiogel AI Lotion |
| II | Active comparator | Drug: Physiogel AI Lotion, Physiogel LotionPhysiogel Lotion twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiogel AI Lotion, Physiogel LotionPhysiogel AI Lotion and Physiogel Lotion is a cosmetic, applied twice daily to dry skin | Drug | I, II |
Primary outcome
Improvement of dry skin Improvement of burning, stinging and pruritus (if present) Improvement of quality of life
Time frame: two weeks
Improvement of burning, stinging and pruritus (if present)
Time frame: two weeks
Improvement of quality of life
Time frame: two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonja Ständer, MD principal investigator
Department of Dermatology, University Hopsital Münster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiogel AI Lotion, Physiogel Lotion in people with Eczema, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of dry skin Improvement of burning, stinging and pruritus (if present) Improvement of quality of life (time frame: two weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2010.