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Evaluating Results of Regularly Applied Emollient - Spray in Atopic Dermatitis Therapy

NCT02763722 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2016-06-14

No results posted yet for this study

Summary

Atopic dermatitis (AD) is a chronic, relapsing, inflammatory skin disease that has potential for profound and far-reaching effects on all aspects of children and their families lives, significantly reducing the quality of life. Atopic dermatitis typically appears in infancy and nowadays is affecting up to 10-30% of children and 2-10% of adults.

Diminished skin barrier is the essential factor that plays a role in the initiation, consolidating and exacerbating AD. Treatment options for AD typically address skin barrier protection or inflammatory components of disease. Proper care using mild and appropriately formulated emollient preparations may provide significant benefits.

In investigators prior study, more than half of pharmacy-derived emollient preparations contained potential contact haptens listed in the European baseline series (EBS), used in diagnosing contact dermatitis.

The primary aim of this study is to demonstrate the efficacy of regularly applied emollient in an atomiser (in the form of oil-in-water emulsion) in maintenance therapy, in children presenting from mild to moderate atopic dermatitis.

In this study 3 visits are planned (for a period of 4 weeks). During each visit investigators will evaluate transepidermal water loss (TEWL), capacitance of outer areas of the stratum corneum as an indirect assessment of skin hydration. Moreover, investigators will assess three-them-severityIndex and the Children's Dermatology Life Quality Index (CDLQI).

The product that participants will use in the study, was prepared at investigators request, in collaboration with the cosmetics company, which according to investigators knowledge at present, will not be benefited from the audit. The following described study project (prospective clinical trial, uncontrolled, open-label) will be conducted within the framework of the statutory tasks of the Department of Pulmonology and Allergology of Children Medical University of Warsaw and is a non-commercial project.

Conditions

Interventions

OTHER

Emollient spray product

All patients will be instructed to use emollients spray on entire skin at least twice a day for four weeks.

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Wojciech Feleszko, MD PhD · Department of Pediatric Respiratory Diseases and Allergy, The Medical University of Warsaw

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02763722 on ClinicalTrials.gov