Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02763722
Recruitment Status : Unknown
Verified June 2016 by Wojciech Feleszko, Medical University of Warsaw.
Recruitment status was:  Recruiting
First Posted : May 5, 2016
Last Update Posted : June 14, 2016
Sponsor:
Information provided by (Responsible Party):
Wojciech Feleszko, Medical University of Warsaw

Brief 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.


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Other: Emollient spray product Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating Results of Regularly Applied Emollient - Spray in Atopic Dermatitis Therapy
Study Start Date : May 2016
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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 Name: Atopic deramtitis group




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Change from scoring atopic dermatitis index (SCORAD Index) [ Time Frame: 4 weeks ]

Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02763722


Contacts
Layout table for location contacts
Contact: Wojciech Feleszko, MD PhD wojciech.feleszko@kliniczny.pl
Contact: Katarzyna Osinka 573480382 katarzyna.osinka@gmail.com

Locations
Layout table for location information
Poland
Katarzyna Osinka Recruiting
Warszawa, Żwirki i Wigury 63A, Poland, 00-090
Contact: Katarzyna Osinka, MD    573480382      
Sponsors and Collaborators
Medical University of Warsaw
Investigators
Layout table for investigator information
Principal Investigator: Wojciech Feleszko, MD PhD Department of Pediatric Respiratory Diseases and Allergy, The Medical University of Warsaw

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Wojciech Feleszko, MD PhD, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02763722     History of Changes
Other Study ID Numbers: KB/4/2016
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Wojciech Feleszko, Medical University of Warsaw:
atopic dermatitis
allergic contact dermatitis
cosmetics
transepidermal water loos
Additional relevant MeSH terms:
Layout table for MeSH terms
Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Emollients
Dermatologic Agents