Efficacy of the "Атопик Soothing Cream" in Children With Mild to Moderate Atopic Dermatitis
NCT ID: NCT02716181
Last Updated: 2018-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
74 participants
INTERVENTIONAL
2016-12-29
2017-05-01
Brief Summary
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Detailed Description
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Investigators concure that combination of these substances in "Атопик Soothing Cream" will be efficacious non-steroidal treatment of Atopic Dermatiti ( AD).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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"Атопик" phase 1
For the first phase of the study, subjects will be randomized to receive treatment with "Атопик Soothing Cream".
"Атопик Soothing Cream"
Topical application of a study cream to involved skin areas twice a day.
Placebo
Topical application of a study placebo cream to involved skin areas twice a day.
Placebo - phase 1
For the first phase of the study, subjects will be randomized to receive treatment with Placebo Cream.
"Атопик Soothing Cream"
Topical application of a study cream to involved skin areas twice a day.
Placebo
Topical application of a study placebo cream to involved skin areas twice a day.
"Атопик" phase 2
The second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream".
"Атопик Soothing Cream"
Topical application of a study cream to involved skin areas twice a day.
Placebo
Topical application of a study placebo cream to involved skin areas twice a day.
Placebo - phase 2
The second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream".
"Атопик Soothing Cream"
Topical application of a study cream to involved skin areas twice a day.
Placebo
Topical application of a study placebo cream to involved skin areas twice a day.
Interventions
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"Атопик Soothing Cream"
Topical application of a study cream to involved skin areas twice a day.
Placebo
Topical application of a study placebo cream to involved skin areas twice a day.
Eligibility Criteria
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Inclusion Criteria
* Must have AD affecting \>5% total body surface area (TBSA) at Baseline
* History of AD for at least 3 months prior to Baseline
* Informed consent/assent in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline and applicable regulations, before completing any study-related procedures
Exclusion Criteria
* Use of systemic corticosteroids, topical calcineurin inhibitors, photo-therapy (PUVA, UVB) or immunosuppressive therapy (eg, cyclosporine) within 14 days prior to Baseline
* Subjects that require systemic therapy for the treatment of AD
* Use of systemic anti-infective or antibiotic treatment within 14 days prior to Baseline
* Subjects who present with clinical conditions other than AD that may interfere with the evaluation (eg, generalized erythroderma, acne, Netherton's Syndrome, psoriasis)
* Any clinically significant skin disease other than AD
* Secondary infection of AD (bacterial, viral or fungal) within the skin area under study or open skin infections in any area at Baseline
* History of severe anxiety and/or depression; any history of suicide attempt
* Subjects with a history of human immunodeficiency virus (HIV) as determined by medical history
* Subjects who, in the opinion of the Investigator(s), would be non-compliant with the visit schedule or study procedures
* Participation in any other investigational trial within 6 weeks of Baseline, or during study conduct
* Chronic condition(s) which are either unstable or not adequately controlled
* Drug or alcohol abuse, mental dysfunction, or other condition limiting the subject's ability to be compliant with study-related procedures
* Any medical condition that may, in the opinion of the Investigator(s), preclude the safe administration of test article or safe participation in the study
1 Year
12 Years
ALL
No
Sponsors
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Samara State Medical University
OTHER
Prof. Zvulunov Alex, Pediatric Dermatology Clinic, Kfar-Saba, Israel.
UNKNOWN
Avanta Trading Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Alex Zvulunov, MD
Role: STUDY_DIRECTOR
Prof. Alex Zvulunov, Pediatric Dermatology Clinic, Israel
Locations
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Pediatric Allergy-Immunology, Department of Pediatrics, Institute of Professional Education
Samara, , Russia
Countries
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References
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Maurya AK, Singh M, Dubey V, Srivastava S, Luqman S, Bawankule DU. alpha-(-)-bisabolol reduces pro-inflammatory cytokine production and ameliorates skin inflammation. Curr Pharm Biotechnol. 2014;15(2):173-81. doi: 10.2174/1389201015666140528152946.
Ebner F, Heller A, Rippke F, Tausch I. Topical use of dexpanthenol in skin disorders. Am J Clin Dermatol. 2002;3(6):427-33. doi: 10.2165/00128071-200203060-00005.
Jirabundansuk P, Ophaswongse S, Udompataikul M. Comparative trial of moisturizer containing spent grain wax, Butyrospermum parkii extract, Argania spinosa kernel oil vs. 1% hydrocortisone cream in the treatment of childhood atopic dermatitis. J Med Assoc Thai. 2014 Aug;97(8):820-6.
Other Identifiers
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166-2015
Identifier Type: -
Identifier Source: org_study_id
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