NCT02920411

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

July 9, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

September 27, 2016

Last Update Submit

July 5, 2019

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Changes in Atopic Dermatitis severity according SCORAD test

    \<16 mild; \>16\<40 moderate; \>40 severe

    At 15 days

Secondary Outcomes (4)

  • Number of atopic dermatitis outbreaks

    At 5 months

  • Duration of stable periods (between outbreaks)

    At 5 months

  • Patient satisfaction assessed by Visual Analog Scales

    At 5 months

  • Treatment compliance assessed by Morisky-Green test

    At 5 months

Study Arms (1)

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

Other: Pediatopic Treatment CreamOther: Pediatopic Body lotion

Interventions

Pediatopic Treatment CreamOTHER

Applied twice a day minimum.

Combined dermatological treatment
Pediatopic Body lotionOTHER

Applied at libitum.

Combined dermatological treatment

Eligibility Criteria

Age1 Month - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children from 1 month to 5 years old
  • Patients with atopic dermatitis mild-moderate with an SCORAD=16-40

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Medic Digest

Badalona, Barcelona, 08912, Spain

Location

Centro médico Quirón Teknon

Barcelona, 08022, Spain

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Sapena Jordi, MD

    Centro Médico Quirón Teknon

    PRINCIPAL INVESTIGATOR

  • M.Carmen Gavilan, MD

    Centro Digest Pediatric Badalona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2016

First Posted

September 30, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

July 9, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)