Dermatitis, AtopicPhase 4NCT01063218
Evaluation of Cetaphil Advanced Usage to Control Light to Moderate Atopic Dermatitis, in Attempt to Reduce the Necessity of Topic Corticoids Application
A Phase 4 study testing Emollient - Cetaphil Advanced in people with Dermatitis, Atopic, run by Galderma Brasil Ltda. at 2 sites in Brazil.
Trial summary
The main goal of this present study is evaluate the decreasing of necessity of topic corticoids usage to control outbreaks of light to moderate atopic dermatitis by using the correct emollients. Read more about this study
- Who is it for?
- Ages 2 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Emollient - Cetaphil Advanced
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesBrazil
- Study dates
- Dec 2009to Oct 2010
- 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 2 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or Female patients
- 2 to 10 years old.
- with light to moderate with no signs of acute/ sub-acute eczema or in activity.
- Subjects can not present inflammatory lesions, erythema, edema, eschar, excoriation and lichens.
- Subjects can present light to moderate dryness.
Who cannot join
- Subjects presenting any serious systemic disease
- Subjects with medical history regarding serious asthma
- Subjects with known or suspected allergy to one of the investigational products
- Subjects with acute atopic eczema or in activity, needing systemic antibiotics
- Subjects with signs of active infections on skin
- Subjects whose parents or legal guardian seem to have difficulty in understand the informed consent form (ICF)
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- Female subjects who are not in pre-menarche period.
- Subjects who need topic corticoids or any other medication that can interfere on Atopic Dermatitis during the study.
- Patient with a wash-out period for treatment less than:
- injectable corticoids: 60 days
- systemic corticoids: 15 days
- topic corticoids: 8 days
- topic immunomodulator: 8 days
- antihistaminic : 48 hours
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital Universitário de Brasília
Brasília, Federal District, 70910-900
Complexo Hospitalar Padre Bento de Guarulhos
Guarulhos, São Paulo, 07051-000
About this study
Official title: Phase IV - Evaluation of Cetaphil Advanced Usage to Control Light to Moderate Atopic Dermatitis, in Attempt to Reduce the Necessity of Topic Corticoids Application
The main goal of this present study is evaluate the decreasing of necessity of topic corticoids usage to control outbreaks of light to moderate atopic dermatitis by using the correct emollients.
- Conditions
- Dermatitis, Atopic
- Being tested
- Emollient - Cetaphil Advanced
- Keywords
- Dermatitis, Atopic, Corticoids, topic, Corticosteroids
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emollient - Cetaphil AdvancedOther
Emollient - Cetaphil Advanced - to be applied twice a day for 20 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Emollient | Other | Only one arm: Emollient (Cetaphil Advanced) to be applied twice a day Receives: Other: Emollient - Cetaphil Advanced |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical evaluation
Measured: Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startDec 2009
- Primary completionSep 2010
- Study completionOct 2010
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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Galderma Brasil Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mario C Pires, MD, Principal investigator, Complexo Hospitalar Padre Bento de GuarulhosIzelda Costa, MD, Principal investigator, Hospital Universitário de Brasília
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063218
- Sponsor's protocol ID
- BR.09.001
- Status last verified
- Mar 2012
- First submitted
- 4 Feb 2010
- Last updated
- 12 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV - Evaluation of Cetaphil Advanced Usage to Control Light to Moderate Atopic Dermatitis, in Attempt to Reduce the Necessity of Topic Corticoids Application
- ClinicalTrials.gov ID
- NCT01063218
- Acronym / sponsor ID
- BR.09.001
- Conditions
- Dermatitis, Atopic
- Keywords
- Dermatitis, Atopic, Corticoids, topic, Corticosteroids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Galderma Brasil Ltda.Industry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 5 Feb 2010 (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 main goal of this present study is evaluate the decreasing of necessity of topic corticoids usage to control outbreaks of light to moderate atopic dermatitis by using the correct emollients.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emollient | Other | Other: Emollient - Cetaphil AdvancedOnly one arm: Emollient (Cetaphil Advanced) to be applied twice a day |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or Female patients
- 2 to 10 years old.
- with light to moderate with no signs of acute/ sub-acute eczema or in activity.
- Subjects can not present inflammatory lesions, erythema, edema, eschar, excoriation and lichens.
- Subjects can present light to moderate dryness.
Key exclusion criteria (14 listed)
- Subjects presenting any serious systemic disease
- Subjects with medical history regarding serious asthma
- Subjects with known or suspected allergy to one of the investigational products
- Subjects with acute atopic eczema or in activity, needing systemic antibiotics
- Subjects with signs of active infections on skin
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 |
|---|---|---|
| Emollient - Cetaphil AdvancedEmollient - Cetaphil Advanced - to be applied twice a day for 20 weeks. | Other | Emollient |
Primary outcome
clinical evaluation
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24
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 12 Mar 2012.
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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.
Mario C Pires, MD principal investigator
Complexo Hospitalar Padre Bento de Guarulhos
Izelda Costa, MD principal investigator
Hospital Universitário de Brasília
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 Emollient - Cetaphil Advanced in people with Dermatitis, Atopic, run by Galderma Brasil Ltda. at 2 sites in Brazil.
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 12 Mar 2012. 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 Brazil. 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?
clinical evaluation (time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24). 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 12 Mar 2012.