Atopic EczemaPhase 4NCT00771121
Effect of Moisturizing Creams on Skin Barrier Function
A Phase 4 study testing urea/lactic acid in people with Atopic Eczema, run by ACO Hud Nordic AB at 2 sites in Sweden.
Trial summary
This study is a randomized, double-blind, placebo-controlled bilateral study on the effect of moisturizing creams on skin barrier function. The hypothesis is that a new active emulsion has a better influence on skin barrier function comapred to its placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Eczema
- What is being tested?
- urea/lactic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 2 sitesSweden
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dry skin barrier disorders such as atopic dermatitis or Malassezia eradicated head and neck dermatitis.
- Rough or clinically normal skin on the volar aspect of the forearm.
- Either gender
- Age between 18 and 65 years
- Written Informed Consent
Who cannot join
- Possible allergy to ingredients in the study medications.
- Use of any concomitant medication that may interfere with the study related activities or assessment of efficacy.
- Any patient related factor suggesting potential poor compliance with study procedures (e.g. psychiatric disorders, history of alcohol or substance abuse).
- Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results.
- Pregnancy or breast feeding, or patients who plan to become pregnant during the course of the study.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites, 2 recruiting
- Recruiting
Sophiahemmet
Stockholm, Stockholm County, 114 86
Lena Holm, Dr, +46 (0)706-382722, lena.holm.ab@telia.com
- Recruiting
Sophiahemmet
Stockholm, Stockholm County, 114 86
Lena Holm, Dr, 0706-382722, lena.holm.ab@telia.com
Lena Holm, Dr
About this study
This study is a randomized, double-blind, placebo-controlled bilateral study on the effect of moisturizing creams on skin barrier function. The hypothesis is that a new active emulsion has a better influence on skin barrier function comapred to its placebo.
- Conditions
- Atopic Eczema
- Being tested
- urea/lactic acid, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urea/lactic acidDrug
new emulsion type
PlaceboDrug
only emulsion base
| Study group | Role | What they receive |
|---|---|---|
| new emulsion | Active comparator | Not described Receives: Drug: urea/lactic acid |
| new emulsion placebo | Placebo comparator | Not described Receives: Drug: Placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic 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 4
Sponsor and investigators
- Lead sponsor
- ACO Hud Nordic AB
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771121
- Sponsor's protocol ID
- ACO2008-CT-01
- Status last verified
- Oct 2008
- First submitted
- 10 Oct 2008
- Last updated
- 13 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Moisturizing Creams on Skin Barrier Function
- ClinicalTrials.gov ID
- NCT00771121
- Acronym / sponsor ID
- ACO2008-CT-01
- Conditions
- Atopic Eczema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- ACO Hud Nordic ABIndustry (pharma, biotech, devices)
- First posted
- 13 Oct 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.
This study is a randomized, double-blind, placebo-controlled bilateral study on the effect of moisturizing creams on skin barrier function. The hypothesis is that a new active emulsion has a better influence on skin barrier function comapred to its placebo.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| new emulsion | Active comparator | Drug: urea/lactic acid |
| new emulsion placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Dry skin barrier disorders such as atopic dermatitis or Malassezia eradicated head and neck dermatitis.
- Rough or clinically normal skin on the volar aspect of the forearm.
- Either gender
- Age between 18 and 65 years
- Written Informed Consent
Key exclusion criteria (5 listed)
- Possible allergy to ingredients in the study medications.
- Use of any concomitant medication that may interfere with the study related activities or assessment of efficacy.
- Any patient related factor suggesting potential poor compliance with study procedures (e.g. psychiatric disorders, history of alcohol or substance abuse).
- Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results.
- Pregnancy or breast feeding, or patients who plan to become pregnant during the course of the study.
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 |
|---|---|---|
| urea/lactic acidnew emulsion type | Drug | new emulsion |
| Placeboonly emulsion base | Drug | new emulsion placebo |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2008.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing urea/lactic acid in people with Atopic Eczema, run by ACO Hud Nordic AB at 2 sites in Sweden.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lena Holm, Dr (+46 (0)706-382722, lena.holm.ab@telia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 13 Oct 2008.