Dermatitis, AtopicPhase 4NCT00846235
Effect of Moisturising Creams on Skin Moisture in Atopic Dermatitis
A Phase 4 study testing Aqualan L, Aqualan Plus, Aqualan L + glycerol ad 20% in people with Dermatitis, Atopic, run by Orion Corporation, Orion Pharma at 1 site in Finland.
Trial summary
The aim of this study is evaluate the effect of three moisturising creams on Stratum corneum (SC) hydratation and barrier function. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Aqualan L, Aqualan Plus, Aqualan L + glycerol ad 20%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2008to May 2009
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Written informed consent (IC) obtained.
- 18-55 years of age, Caucasian, Finnish speaking, male or female subjects.
- Weight at least 50 kg.
- Body mass index (BMI) 18-30 kg/m2.
- Clinical assessment for the diagnosis of mild or moderate atopic dermatitis
Who cannot join
- Any clinically relevant medical condition judged by the investigator.
- Any known allergy to ingredients of the test treatments.
- Any systemic immunosuppressive or cortisone medication.
- UV-Light therapy and sunlight exposure within 30 days prior to the start of the study and during study.
- Any abnormal physical finding which may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study.
- Anticipated difficulty related to stopping of caffeine intake during study centre visits.
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- Current use of nicotine containing products more than 5 cigarettes (or equivalent)/day and inability to refrain from the use of nicotine containing products during the study.
- Recent or current drug abuse or suspected abuse or positive result in screening of drug abuse.
- Recent or current alcohol abuse (more than 16 units/week for women and more than 21 units/week for men) or suspected abuse.
- Participation in another clinical study within 30 days prior to the start of the present study.
- Predictable poor compliance or inability to communicate well with the investigator.
- Inability to participate in all treatment periods.
- Pregnant or lactating females.
- Females of childbearing potential if they are not using proper contraception (hormonal contraception, intrauterine device (IUD) or surgical sterilization, spermicidal foam in conjunction with condom on male partner) (Note: women of childbearing potential with no current sexual relationship can be included without contraception according to the judgement of the investigator).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Effect of Moisturising Cream on Skin Moisture in Atopic Dermatitis
The aim of this study is evaluate the effect of three moisturising creams on Stratum corneum (SC) hydratation and barrier function.
Read the detailed description
In the present study, 24 subjects with AD will be treated for 3 weeks twice daily by using 3 different moisturising creams. Duration of the study is based on literature. Various moisturising creams containing glycerol have been reported to be beneficial for AD lesions. The optimal glycerol content in moisturising creams is not known. The secondary objective is the comparison of change in the SC water content and in the TEWL from the skin surface from the baseline to the end of study between different moisturizing creams containing different amount of glycerol.
Change in the SC water content and in the TEWL can be demonstrated with noninvasive instrumental measurement. The treated skin will be followed up instrumentally, and one measurement area will serve as an untreated control. The primary evaluation is the comparison of change in the SC water content and in the TEWL on the skin surface from the baseline to the end of study between the 4 treatments.
- Conditions
- Dermatitis, Atopic
- Being tested
- Aqualan L, Aqualan Plus, Aqualan L + glycerol ad 20%
- Keywords
- Dermatitis, Atopic, Moisturising cream, Skin
- Medical subject headings
- Dermatitis, Atopic, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aqualan L, Aqualan Plus, Aqualan L + glycerol ad 20%Other
moisturising cream twice daily three weeks
| Study group | Role | What they receive |
|---|---|---|
| Moisturising cream | Experimental | Not described Receives: Other: Aqualan L, Aqualan Plus, Aqualan L + glycerol ad 20% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin hydratation and transepidermal water loss.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startDec 2008
- Primary completionMar 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pirjo Nykänen, PhD, Study director, Orion Pharma, R&D, Translational Sciences, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846235
- Sponsor's protocol ID
- 2934004
- Status last verified
- Oct 2009
- First submitted
- 13 Feb 2009
- Last updated
- 8 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Effect of Moisturising Cream on Skin Moisture in Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00846235
- Acronym / sponsor ID
- 2934004
- Conditions
- Dermatitis, Atopic
- Keywords
- Dermatitis, Atopic, Moisturising cream, Skin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 18 Feb 2009 (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.
The aim of this study is evaluate the effect of three moisturising creams on Stratum corneum (SC) hydratation and barrier function.
Detailed description
In the present study, 24 subjects with AD will be treated for 3 weeks twice daily by using 3 different moisturising creams. Duration of the study is based on literature. Various moisturising creams containing glycerol have been reported to be beneficial for AD lesions. The optimal glycerol content in moisturising creams is not known. The secondary objective is the comparison of change in the SC water content and in the TEWL from the skin surface from the baseline to the end of study between different moisturizing creams containing different amount of glycerol.
Change in the SC water content and in the TEWL can be demonstrated with noninvasive instrumental measurement. The treated skin will be followed up instrumentally, and one measurement area will serve as an untreated control. The primary evaluation is the comparison of change in the SC water content and in the TEWL on the skin surface from the baseline to the end of study between the 4 treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moisturising cream | Experimental | Other: Aqualan L, Aqualan Plus, Aqualan L + glycerol ad 20% |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Written informed consent (IC) obtained.
- 18-55 years of age, Caucasian, Finnish speaking, male or female subjects.
- Weight at least 50 kg.
- Body mass index (BMI) 18-30 kg/m2.
- Clinical assessment for the diagnosis of mild or moderate atopic dermatitis
Key exclusion criteria (14 listed)
- Any clinically relevant medical condition judged by the investigator.
- Any known allergy to ingredients of the test treatments.
- Any systemic immunosuppressive or cortisone medication.
- UV-Light therapy and sunlight exposure within 30 days prior to the start of the study and during study.
- Any abnormal physical finding which may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in 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 |
|---|---|---|
| Aqualan L, Aqualan Plus, Aqualan L + glycerol ad 20%moisturising cream twice daily three weeks | Other | Moisturising cream |
Primary outcome
Skin hydratation and transepidermal water loss.
Time frame: 3 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 8 Oct 2009.
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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.
Pirjo Nykänen, PhD study director
Orion Pharma, R&D, Translational Sciences, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aqualan L, Aqualan Plus, Aqualan L + glycerol ad 20% in people with Dermatitis, Atopic, run by Orion Corporation, Orion Pharma at 1 site in Finland.
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 14 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 8 Oct 2009. 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 Finland. 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.
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?
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?
Skin hydratation and transepidermal water loss. (time frame: 3 weeks). 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 8 Oct 2009.