Atopic DermatitisKAOSNCT02920411
Effectiveness of a Combined Dermatological Treatment in Children With Atopic Dermatitis
A study testing Pediatopic Treatment Cream and Pediatopic Body lotion in people with Atopic Dermatitis, run by Laboratorios Ordesa at 2 sites in Spain.
Trial summary
The purpose of this study is to determine the effectiveness of a combined dermatological treatment in children up to 5 years old with mild or moderated atopic dermatitis. Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Pediatopic Treatment Cream and Pediatopic Body lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesSpain
- Study dates
- Oct 2016to Oct 2018
- Phase
- Interventional
- 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 1 month to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children from 1 month to 5 years old
- Patients with atopic dermatitis mild-moderate with an SCORAD=16-40
Who cannot join
- Other dermatological diseases that could interfere with the study results
- Corticoids use during 3 weeks prior to the study
- Antibiotics use to treat atopic dermatitis during 3 weeks prior to the study
- Use of topical immunomodulators
- Concurrent use of other emollients
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Centre Medic Digest
Badalona, Barcelona, 08912
Centro médico Quirón Teknon
Barcelona, 08022
About this study
Official title: Estudio Piloto Sobre la Efectividad de la acción Conjunta de Una Crema Corporal y un bálsamo Corporal en niños Con Dermatitis atópica
The purpose of this study is to determine the effectiveness of a combined dermatological treatment in children up to 5 years old with mild or moderated atopic dermatitis.
Read the detailed description
The intensive cream and body lotion of the PediATOPIC® products are two emollients expressly formulated to serve as adjuvants in the management of Atopic Dermatitis. Both products contain Dermosense complex®, a complex that includes 3 products: Bodyfensine peptide® (inductor of dephensine synthesis against microbial aggressions), Unimoist® (the mimetizing complex of the skin's natural hydration factor), and Ramnosoft® (polysaccharide that inhibits the adhesion of pro-inflammatory drugs and bacteria, while limiting the spread of inflammatory reactions in skin cells). They also contain Bisabolol, (plant extract with anti-inflammatory, anti-irritant and antimicrobial properties) and Panthenol (Pro vitamin B5 that accelerates the skin's natural regeneration process).
- Conditions
- Atopic Dermatitis
- Being tested
- Pediatopic Treatment Cream, Pediatopic Body lotion
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatopic Treatment CreamOther
Applied twice a day minimum.
Pediatopic Body lotionOther
Applied at libitum.
| Study group | Role | What they receive |
|---|---|---|
| Combined dermatological treatment | Experimental | A combined treatment of two emollient products will be applied:
* Pediatopic treatment cream during acute stages of atopic dermatitis and
* Pediatopic body lotion during stable stages Receives: Other: Pediatopic Treatment Cream; Other: Pediatopic Body lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Atopic Dermatitis severity according SCORAD test
<16 mild; >16<40 moderate; >40 severe
Measured: At 15 days
Secondary outcomes (4)
Number of atopic dermatitis outbreaks
Number of episodes
Measured: At 5 months
Duration of stable periods (between outbreaks)
Register of days without outbreaks
Measured: At 5 months
Patient satisfaction assessed by Visual Analog Scales
Validated scale for patients <5 years
Measured: At 5 months
Treatment compliance assessed by Morisky-Green test
Adherence / Compliance
Measured: At 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2018
- Study completionOct 2018
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Ordesa
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clever Instruments S.L.
- Responsible party
- Sponsor
- Investigators
- Sapena Jordi, MD, Principal investigator, Centro Médico Quirón TeknonM.Carmen Gavilan, MD, Principal investigator, Centro Digest Pediatric Badalona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920411
- Sponsor's protocol ID
- KAOS-02-16
- Acronym
- KAOS
- Status last verified
- Jul 2019
- First submitted
- 27 Sep 2016
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudio Piloto Sobre la Efectividad de la acción Conjunta de Una Crema Corporal y un bálsamo Corporal en niños Con Dermatitis atópica
- ClinicalTrials.gov ID
- NCT02920411
- Acronym / sponsor ID
- KAOS / KAOS-02-16
- Conditions
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Laboratorios OrdesaIndustry (pharma, biotech, devices)
- Collaborators
- Clever Instruments S.L.
- Study start
- Oct 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 30 Sep 2016 (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 determine the effectiveness of a combined dermatological treatment in children up to 5 years old with mild or moderated atopic dermatitis.
Detailed description
The intensive cream and body lotion of the PediATOPIC® products are two emollients expressly formulated to serve as adjuvants in the management of Atopic Dermatitis. Both products contain Dermosense complex®, a complex that includes 3 products: Bodyfensine peptide® (inductor of dephensine synthesis against microbial aggressions), Unimoist® (the mimetizing complex of the skin's natural hydration factor), and Ramnosoft® (polysaccharide that inhibits the adhesion of pro-inflammatory drugs and bacteria, while limiting the spread of inflammatory reactions in skin cells). They also contain Bisabolol, (plant extract with anti-inflammatory, anti-irritant and antimicrobial properties) and Panthenol (Pro vitamin B5 that accelerates the skin's natural regeneration process).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined dermatological treatment | Experimental | Other: Pediatopic Treatment Cream, Other: Pediatopic Body lotionA combined treatment of two emollient products will be applied: * Pediatopic treatment cream during acute stages of atopic dermatitis and * Pediatopic body lotion during stable stages |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children from 1 month to 5 years old
- Patients with atopic dermatitis mild-moderate with an SCORAD=16-40
Key exclusion criteria (5 listed)
- Other dermatological diseases that could interfere with the study results
- Corticoids use during 3 weeks prior to the study
- Antibiotics use to treat atopic dermatitis during 3 weeks prior to the study
- Use of topical immunomodulators
- Concurrent use of other emollients
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 |
|---|---|---|
| Pediatopic Treatment CreamApplied twice a day minimum. | Other | Combined dermatological treatment |
| Pediatopic Body lotionApplied at libitum. | Other | Combined dermatological treatment |
Primary outcome
Changes in Atopic Dermatitis severity according SCORAD test
Time frame: At 15 days
<16 mild; >16<40 moderate; >40 severe
4 secondary outcomes
Number of atopic dermatitis outbreaks
Time frame: At 5 months
Duration of stable periods (between outbreaks)
Time frame: At 5 months
Patient satisfaction assessed by Visual Analog Scales
Time frame: At 5 months
Treatment compliance assessed by Morisky-Green test
Time frame: At 5 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 9 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Sapena Jordi, MD principal investigator
Centro Médico Quirón Teknon
M.Carmen Gavilan, MD principal investigator
Centro Digest Pediatric Badalona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pediatopic Treatment Cream and Pediatopic Body lotion in people with Atopic Dermatitis, run by Laboratorios Ordesa at 2 sites in Spain.
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 2 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 9 Jul 2019. 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 Spain. 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.
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?
Changes in Atopic Dermatitis severity according SCORAD test (time frame: At 15 days). 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 9 Jul 2019.