Atopic DermatitisNCT02763722
Evaluating Results of Regularly Applied Emollient - Spray in Atopic Dermatitis Therapy
A study testing Emollient spray product in people with Atopic Dermatitis, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Emollient spray product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 sitePoland
- Study dates
- May 2016to Oct 2016
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of atopic dermatitis (AD) using the criteria Hanifin and Rajka
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Wojciech Feleszko, MD PhD contact
Poland1 site, 1 recruiting
- Recruiting
Katarzyna Osinka
Warsaw, Żwirki I Wigury 63A, 00-090
Katarzyna Osinka, MD, 573480382
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Emollient spray product
- Keywords
- atopic dermatitis, allergic contact dermatitis, cosmetics, transepidermal water loos
- Medical subject headings
- Dermatitis, Atopic, Dermatitis, Allergic Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emollient spray productOther
Also called Atopic deramtitis group
All patients will be instructed to use emollients spray on entire skin at least twice a day for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Emollient spray product | Experimental | 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. Receives: Other: Emollient spray product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Transepidermal Water Loss (TEWL)
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.
Measured: 4 weeks
Secondary outcomes (2)
Change from the Children's Dermatology Life Quality Index (CDLQI )
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.
Measured: 4 weeks
Change from scoring atopic dermatitis index (SCORAD Index)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wojciech Feleszko, Medical University of Warsaw
- Investigators
- Wojciech Feleszko, MD PhD, Principal investigator, Department of Pediatric Respiratory Diseases and Allergy, The Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763722
- Sponsor's protocol ID
- KB/4/2016
- Status last verified
- Jun 2016
- First submitted
- 25 Apr 2016
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Eichenfield LF, Tom WL, Berger TG, Krol A, Paller AS, Schwarzenberger K, Bergman JN, Chamlin SL, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Feldman SR, Hanifin JM, Margolis DJ, Silverman RA, Simpson EL, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014 Jul;71(1):116-32. doi: 10.1016/j.jaad.2014.03.023. Epub 2014 May 9.
PubMed 24813302Zukiewicz-Sobczak WA, Adamczuk P, Wroblewska P, Zwolinski J, Chmielewska-Badora J, Krasowska E, Galinska EM, Cholewa G, Piatek J, Kozlik J. Allergy to selected cosmetic ingredients. Postepy Dermatol Alergol. 2013 Oct;30(5):307-10. doi: 10.5114/pdia.2013.38360. Epub 2013 Oct 30.
PubMed 24353491
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Results of Regularly Applied Emollient - Spray in Atopic Dermatitis Therapy
- ClinicalTrials.gov ID
- NCT02763722
- Acronym / sponsor ID
- KB/4/2016
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, allergic contact dermatitis, cosmetics, transepidermal water loos
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 5 May 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emollient spray product | Experimental | Other: Emollient spray productStudy 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. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of atopic dermatitis (AD) using the criteria Hanifin and Rajka
Key exclusion criteria (1 listed)
- 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)
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 |
|---|---|---|
| Emollient spray productAlso: Atopic deramtitis groupAll patients will be instructed to use emollients spray on entire skin at least twice a day for four weeks. | Other | Emollient spray product |
Primary outcome
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.
2 secondary outcomes
Change from the Children's Dermatology Life Quality Index (CDLQI )
Time frame: 4 weeks
Change from scoring atopic dermatitis index (SCORAD Index)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2016.
- Background: PubMed 24813302Eichenfield LF, Tom WL, Berger TG, Krol A, Paller AS, Schwarzenberger K, Bergman JN, Chamlin SL, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Feldman SR, Hanifin JM, Margolis DJ, Silverman RA, Simpson EL, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014 Jul;71(1):116-32. doi: 10.1016/j.jaad.2014.03.023. Epub 2014 May 9.
- Background: PubMed 24353491Zukiewicz-Sobczak WA, Adamczuk P, Wroblewska P, Zwolinski J, Chmielewska-Badora J, Krasowska E, Galinska EM, Cholewa G, Piatek J, Kozlik J. Allergy to selected cosmetic ingredients. Postepy Dermatol Alergol. 2013 Oct;30(5):307-10. doi: 10.5114/pdia.2013.38360. Epub 2013 Oct 30.
- our prior studyLink provided by the sponsor.
- similar method of the study projectLink provided by the sponsor.
- 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.
Wojciech Feleszko, MD PhD contact
Wojciech Feleszko, MD PhD principal investigator
Department of Pediatric Respiratory Diseases and Allergy, The Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emollient spray product in people with Atopic Dermatitis, run by Medical University of Warsaw at 1 site in Poland.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wojciech Feleszko, MD PhD (wojciech.feleszko@kliniczny.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Transepidermal Water Loss (TEWL) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02763722, which also lists 2 linked publications.
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 14 Jun 2016.