Atopic DermatitisPhase 3NCT01779258
Emollients in the Management of Atopic Dermatitis
A Phase 3 study testing glycerol, paraffin (liquid and white soft), Atopiclair® and Locatop@ in people with Atopic Dermatitis, run by Pierre Fabre Medicament at 15 sites in 5 countries.
Trial summary
The purpose of this study is to confirm that emollients play a major role in the maintenance therapy after clearing of inflammatory lesions and can reduce occurrence of flares in children with atopic dermatitis. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- glycerol, paraffin (liquid and white soft), Atopiclair® and Locatop@
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- 15 sitesin 5 countries
- Study dates
- Feb 2013to Feb 2014
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 2 and 6 years included,
- Presenting with atopic dermatitis, with at least one duly documented flare treated by corticosteroids within the previous 6 months, and presenting a current flare (objective Scoring for Atopic Dermatitis (SCORAD score) is [15-40] at inclusion),
- After treatment of the current flare, patients should have for randomization an Objective SCORAD score < 15, with Xerosis intensity≥ 1 and no subjective signs
Who cannot join
- Severe form of atopic dermatitis requiring either systemic corticosteroid treatment and/or antibiotic or antiviral treatment and/or hospitalisation,
- Primary bacterial, viral, fungal or parasitic skin infection,
- Ulcerated lesions, acne or rosacea,
- Dermatological disease other than atopic dermatitis which could interfere with the assessment,
- Immunosuppression,
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
Romania6 sites
Study site
Brasov
Study site
Bucharest
Study site
Craiova
Study site
Iași
Study site
Sibiu
Study site
Targu Mureş
Poland4 sites
Study site
Lodz
Study site
Płock
Study site
Pruszków
Study site
Warsaw
About this study
Official title: Emollients in the Management of Atopic Dermatitis in Children: Prevention of Flares.
The purpose of this study is to confirm that emollients play a major role in the maintenance therapy after clearing of inflammatory lesions and can reduce occurrence of flares in children with atopic dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- glycerol, paraffin (liquid and white soft), Atopiclair®, Locatop@, Locapred@
- Keywords
- xerosis, dry skin, dermatitis, eczema, emollient, corticosteroid, flare
- Medical subject headings
- Dermatitis, Atopic, Dermatitis, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glycerol, paraffin (liquid and white soft)Drug
Also called Dexeryl®
1 application in the morning and in the evening
Atopiclair®Device
1 application in the morning, in the afternoon and in the evening
Locatop@Drug
During the Run-In period:
1 application in the morning and in the evening during a maximum of 21 days
Locapred@Drug
During the 3 months study treatment:
1 application in the evening in case of flare "
| Study group | Role | What they receive |
|---|---|---|
| Group 2 | Other | Active control arm, Locatop@, Locapred@ Receives: Device: Atopiclair®; Drug: Locatop@; Drug: Locapred@ |
| Group 3 | Other | Absence of emollient treatment, Locatop@, Locapred@ Receives: Drug: Locatop@; Drug: Locapred@ |
| Group 1 | Experimental | glycerol, paraffin (liquid and white soft), Locatop@
, Locapred@ Receives: Drug: glycerol, paraffin (liquid and white soft); Drug: Locatop@; Drug: Locapred@ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with at least one flare over the treatment period
A flare is defined as following: measurable increased extend or intensity of lesions in less than 2 weeks under continued treatment corresponding to a significant increase in medical score (> 25%) or to the introduction of a new line of therapy(topical corticosteroid).
Measured: 12 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- None (open label)
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779258
- Sponsor's protocol ID
- V00034 CR 3 13 1B
- Other IDs
- 2012-004621-24
- Status last verified
- Feb 2014
- First submitted
- 28 Jan 2013
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emollients in the Management of Atopic Dermatitis in Children: Prevention of Flares.
- ClinicalTrials.gov ID
- NCT01779258
- Acronym / sponsor ID
- V00034 CR 3 13 1B
- Conditions
- Atopic Dermatitis
- Keywords
- xerosis, dry skin, dermatitis, eczema, emollient, corticosteroid, flare
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 30 Jan 2013 (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 purpose of this study is to confirm that emollients play a major role in the maintenance therapy after clearing of inflammatory lesions and can reduce occurrence of flares in children with atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 2 | Other | Device: Atopiclair®, Drug: Locatop@, Drug: Locapred@Active control arm, Locatop@, Locapred@ |
| Group 3 | Other | Drug: Locatop@, Drug: Locapred@Absence of emollient treatment, Locatop@, Locapred@ |
| Group 1 | Experimental | Drug: glycerol, paraffin (liquid and white soft), Drug: Locatop@, Drug: Locapred@glycerol, paraffin (liquid and white soft), Locatop@ , Locapred@ |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age between 2 and 6 years included,
- Presenting with atopic dermatitis, with at least one duly documented flare treated by corticosteroids within the previous 6 months, and presenting a current flare (objective Scoring for Atopic Dermatitis (SCORAD score) is [15-40] at inclusion),
- After treatment of the current flare, patients should have for randomization an Objective SCORAD score < 15, with Xerosis intensity≥ 1 and no subjective signs
Key exclusion criteria (5 listed)
- Severe form of atopic dermatitis requiring either systemic corticosteroid treatment and/or antibiotic or antiviral treatment and/or hospitalisation,
- Primary bacterial, viral, fungal or parasitic skin infection,
- Ulcerated lesions, acne or rosacea,
- Dermatological disease other than atopic dermatitis which could interfere with the assessment,
- Immunosuppression,
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 |
|---|---|---|
| glycerol, paraffin (liquid and white soft)Also: Dexeryl®1 application in the morning and in the evening | Drug | Group 1 |
| Atopiclair®1 application in the morning, in the afternoon and in the evening | Device | Group 2 |
| Locatop@During the Run-In period: 1 application in the morning and in the evening during a maximum of 21 days | Drug | Group 1, Group 2, Group 3 |
| Locapred@During the 3 months study treatment: 1 application in the evening in case of flare " | Drug | Group 1, Group 2, Group 3 |
Primary outcome
Percentage of patients with at least one flare over the treatment period
Time frame: 12 weeks of treatment.
A flare is defined as following: measurable increased extend or intensity of lesions in less than 2 weeks under continued treatment corresponding to a significant increase in medical score (> 25%) or to the introduction of a new line of therapy(topical corticosteroid).
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 19 Feb 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing glycerol, paraffin (liquid and white soft), Atopiclair® and Locatop@ in people with Atopic Dermatitis, run by Pierre Fabre Medicament at 15 sites in 5 countries.
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 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: finished, as of the sponsor's last update on 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Romania, Poland, Estonia, France, Lithuania. 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?
Percentage of patients with at least one flare over the treatment period (time frame: 12 weeks of treatment.). 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 19 Feb 2014.