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

June 13, 2016 updated by: Wojciech Feleszko, Medical University of Warsaw

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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. The skin exposed to aeroallergens (pollen, pet dander, dust mites), or food allergens (eggs, milk, wheat protein, chocolate, strawberry), hard water, and soaps and detergents, loses the protective barrier composed of lipids (ie. Lipid) and becomes the victim of harmful, exogenous substances.

The main symptoms of atopic dermatitis are redness and dry skin, itching, moreover patients are susceptible to recurrent superficial skin infections. Skin lesions in AD are mostly located on the elbows and knees, face and neck, however they can spans the entire body. 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.

Previous observations indicated to be reasonable to selection carefully composition of emollient preparations. In investigators prior study, more than half of emollient preparations, available in online drugstores, contained potential contact sensitizers, included to 28, the most common, haptens listed in the European baseline series (EBS), used in diagnosing contact dermatitis. A significant number of investigated products contained at least two different haptens which may threaten unpredictable allergic reactions in the case of concomitance of various allergens.

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.

The composition of the tested emollient is typical and based on the frequently occurring substances found in public preparations of this kind.

Emollient spray (composition INCI):

Aqua, Glycerin, Aqua, Parfum, Glyceryl Caprylate, Allantoin, Xanthan Gum, Butyrospermum Parkii Butter, Adansonia digitata Seed Oil, Oenothera Biennis Oil, Perilla ocymoides Seed Oil, Tocopheryl Acetate, Palm Kernel Glycerides, Squalane, behenyl Alcohol, Glyceryl Stearate, Palmitic Acid, Stearic Acid, Lecythin, Cetyl Alcohol, Myristyl Alcohol, Ceramide NP, Glyceryl Stearate Citrate, Cetearyl Alcohol, Tocopheryl Acetate, Caprylic / Capric Trigliceride, Dicaprylyl Carbonate, Tocopherol, Etylhexyl Stearate.

The product that will be used in the study (emollients in spray- composition of the product given above) 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 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.

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
    • Żwirki i Wigury 63A
      • Warszawa, Żwirki i Wigury 63A, Poland, 00-090
        • Recruiting
        • Katarzyna Osinka
        • Contact:
          • Katarzyna Osinka, MD
          • Phone Number: 573480382

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

A. Clinical diagnosis of atopic dermatitis (AD) using the criteria Hanifin and Rajka

Exclusion Criteria:

A. severe atopic dermatitis (SCORAD Index over 40) B. oral steroids dose over 1 mg / kg. eq prednisolone or other oral immunosuppressive drugs during the last 3 days C. topical steroids or calcineurin inhibitors used more than 1 week D. viral skin infection (eg. Eczema herpeticum) or bacterial infections of the skin, E. severe systemic disease (kidney failure, heart disease, immunodeficiency)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Emollient spray product

Study design

A 3 visits are planned:

0 week (first visit) 2nd week (second visit) 4th week (third visit)

B. During each visit will be made:

  1. The clinical examination (including an assessment of any adverse effects)
  2. Evaluation of transepidermal water loss (TEWL) and capacitance of outer areas of the stratum corneum as an indirect assessment of skin hydration,
  3. fill out questionnaires CDLQI (The Children's Dermatology Life Quality Index)
  4. will assess VAS (visual analogue scale)

C. All patients will be instructed to use emollients spray the entire surface of the skin at least twice daily for four weeks.
Other: Emollient spray product
All patients will be instructed to use emollients spray on entire skin at least twice a day for four weeks.
Other Names:
  • Atopic deramtitis group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Transepidermal Water Loss (TEWL)
Time Frame: 4 weeks
Standardized measurements of evaporation percutaneous (transepidermal water loss, TEWL) and capacitance outer areas of the stratum corneum giving indirect evaluation of skin hydration will be performed by the same researcher. The tests will be carried out always at the same point of the body.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from the Children's Dermatology Life Quality Index (CDLQI )
Time Frame: 4 weeks
Courtesy of Professor A. Y. Finlay and Dr. M. S. Lewis-Jones of the Medical University of Cardiff during the study will be used a questionnaire about quality of life in children suffering from dermatological diseases.
4 weeks
Change from scoring atopic dermatitis index (SCORAD Index)
Time Frame: 4 weeks
4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from three-item-severity indicator (TIS)
Time Frame: 4 weeks
TIS evaluats the severity of erythema (max. 3 points), swelling (max. 3 points) and scratchs (max. 3 points), the maximum value of TIS = 9.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimate)

May 5, 2016

Study Record Updates

Last Update Posted (Estimate)

June 14, 2016

Last Update Submitted That Met QC Criteria

June 13, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB/4/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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