Atopic EczemaPhase 3NCT00576238
Skin Tolerance Study of Betamethasone Creams in Atopic Eczema and the Preventative Properties of a Moisturiser
A Phase 3 study testing betamethasone valerate and urea in people with Atopic Eczema, run by ACO Hud Nordic AB at 5 sites in Sweden.
Trial summary
Topical steroid creams as well as moisturizing creams are important parts of the treatment strategy of atopic eczema. This study aims to investigate the tolerance of a new strong steroid cream in comparison to an already marketed reference cream with equal amount of active but with different cream vehicle. 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?
- betamethasone valerate and urea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 5 sitesSweden
- Study dates
- Jan 2004to Feb 2008
- Phase
- Phase 3
- 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
- Females and males between 18 and 65 years of age
- Caucasian
- AD according to the criteria of Hanifin and Rajka (12) with eczematous lesions corresponding to an Atopic Dermatitis Severity Index (ADSI) (13) score of at least 6 on any of the following areas: arms, legs, chest, abdomen or back
- No serious health conditions that may interfere with the study
- Written informed consent
Who cannot join
- Eczematous regions exclusively in intertriginous areas or in the face
- Use of topical steroids or any other dermatologic drug therapy (moisturising creams allowed) in the study area or light therapy within the preceding 2 weeks
- Use of oral steroids within 1 month prior to the study
- Use of concurrent medication e.g. medication that may interfere with the study related activities
- Factors suggesting low compliance with study procedures
- Possible allergy to ingredients in the study medications
- Pregnancy or breast feeding
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Sweden5 sites
Nacka hudmottagning
Nacka, 13183
Nacka närsjukhus
Nacka, 13183
Sophiahemmet
Stockholm, 11486
Hudkliniken, Danderyds sjukhus
Stockholm, 18288
Läkarhuset Vällingby
Vällingby, 16862
About this study
Official title: A Multi Centre, Parallel, Randomised Study of the Skin Tolerance of Betamethasone Creams on Atopic Eczema and the Influence of Moisturiser Treatment on the Recurrence of Eczema
Topical steroid creams as well as moisturizing creams are important parts of the treatment strategy of atopic eczema. This study aims to investigate the tolerance of a new strong steroid cream in comparison to an already marketed reference cream with equal amount of active but with different cream vehicle. The second part of the study will investigate the possible preventative property of a moisturizing cream on skin that has been previously cleared from eczema.
- Conditions
- Atopic Eczema
- Being tested
- betamethasone valerate, urea
- Keywords
- Atopic eczema, Topical corticosteroid
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
betamethasone valerateDrug
Also called Betnoderm 0,1 % kräm
Topical application according to a fixed schedule for three weeks
betamethasone valerateDrug
Also called Betnovat kräm 0,1%
Topical application according to a fixed schedule for three weeks
ureaDrug
Also called Canoderm kräm 5%
Topical application twice daily for up to 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1:1 | Experimental | Part 1 - eczema treatment Receives: Drug: betamethasone valerate |
| 1:2 | Active comparator | Part 1 - eczema treatment Receives: Drug: betamethasone valerate |
| 2:1 | Experimental | Part 2 - maintenance treatment Receives: Drug: urea |
| 2:2 | No intervention | Part 2 - maintenance treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the compatibility of the skin with the new formulation in comparison to the reference medication.
Measured: 3 weeks
To study the effect of maintenance therapy with an emollient cream on the possible recurrence of atopic eczema.
Measured: Up to 6 months
Secondary outcomes (3)
To study cosmetic acceptance of the corticosteroids
Measured: 3 weeks
To study the safety of corticosteroid treatment.
Measured: 3 weeks
To study the safety of maintenance treatment.
Measured: Up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startJan 2004
- Study completionFeb 2008
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- ACO Hud Nordic AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Berit Berne, MD, Principal investigator, Hudkliniken, Akademiska sjukhuset, Uppsala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576238
- Sponsor's protocol ID
- ACO/02/08
- Status last verified
- Oct 2008
- First submitted
- 18 Dec 2007
- 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
- A Multi Centre, Parallel, Randomised Study of the Skin Tolerance of Betamethasone Creams on Atopic Eczema and the Influence of Moisturiser Treatment on the Recurrence of Eczema
- ClinicalTrials.gov ID
- NCT00576238
- Acronym / sponsor ID
- ACO/02/08
- Conditions
- Atopic Eczema
- Keywords
- Atopic eczema, Topical corticosteroid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- ACO Hud Nordic ABIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Study completion
- Feb 2008 (actual)
- First posted
- 19 Dec 2007 (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.
Topical steroid creams as well as moisturizing creams are important parts of the treatment strategy of atopic eczema. This study aims to investigate the tolerance of a new strong steroid cream in comparison to an already marketed reference cream with equal amount of active but with different cream vehicle. The second part of the study will investigate the possible preventative property of a moisturizing cream on skin that has been previously cleared from eczema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1:1 | Experimental | Drug: betamethasone valeratePart 1 - eczema treatment |
| 1:2 | Active comparator | Drug: betamethasone valeratePart 1 - eczema treatment |
| 2:1 | Experimental | Drug: ureaPart 2 - maintenance treatment |
| 2:2 | No intervention | –Part 2 - maintenance treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Females and males between 18 and 65 years of age
- Caucasian
- AD according to the criteria of Hanifin and Rajka (12) with eczematous lesions corresponding to an Atopic Dermatitis Severity Index (ADSI) (13) score of at least 6 on any of the following areas: arms, legs, chest, abdomen or back
- No serious health conditions that may interfere with the study
- Written informed consent
Key exclusion criteria (7 listed)
- Eczematous regions exclusively in intertriginous areas or in the face
- Use of topical steroids or any other dermatologic drug therapy (moisturising creams allowed) in the study area or light therapy within the preceding 2 weeks
- Use of oral steroids within 1 month prior to the study
- Use of concurrent medication e.g. medication that may interfere with the study related activities
- Factors suggesting low compliance with study procedures
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 |
|---|---|---|
| betamethasone valerateAlso: Betnoderm 0,1 % krämTopical application according to a fixed schedule for three weeks | Drug | 1:1 |
| betamethasone valerateAlso: Betnovat kräm 0,1%Topical application according to a fixed schedule for three weeks | Drug | 1:2 |
| ureaAlso: Canoderm kräm 5%Topical application twice daily for up to 6 months | Drug | 2:1 |
Primary outcome
To study the compatibility of the skin with the new formulation in comparison to the reference medication.
Time frame: 3 weeks
To study the effect of maintenance therapy with an emollient cream on the possible recurrence of atopic eczema.
Time frame: Up to 6 months
3 secondary outcomes
To study cosmetic acceptance of the corticosteroids
Time frame: 3 weeks
To study the safety of corticosteroid treatment.
Time frame: 3 weeks
To study the safety of maintenance treatment.
Time frame: Up to 6 months.
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 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.
Berit Berne, MD principal investigator
Hudkliniken, Akademiska sjukhuset, Uppsala
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing betamethasone valerate and urea in people with Atopic Eczema, run by ACO Hud Nordic AB at 5 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 7 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 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 5 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To study the compatibility of the skin with the new formulation in comparison to the reference medication. (time frame: 3 weeks). The study lists 2 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 13 Oct 2008.