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Efficacy of the "Атопик Soothing Cream" in Children With Mild to Moderate Atopic Dermatitis

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: NCT02716181
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : January 11, 2018
Sponsor:
Collaborators:
Samara State Medical University
Prof. Zvulunov Alex, Pediatric Dermatology Clinic, Kfar-Saba, Israel.
Information provided by (Responsible Party):
Avanta Trading Ltd.

Brief Summary:
A Double-Blind Randomized Placebo-Controlled Trial to Evaluate the Efficacy of the "Атопик Soothing Cream" in Children with Mild to Moderate Atopic Dermatitis

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Device: "Атопик Soothing Cream" Device: Placebo Not Applicable

Detailed Description:

"Атопик Soothing Cream" is a lipid complex composed of barley grain, Butyrospermum Parkii and Argania Spinosa Kernel oil, in a mixture with panthenol and bisabolol.

Investigators concure that combination of these substances in "Атопик Soothing Cream" will be efficacious non-steroidal treatment of Atopic Dermatiti ( AD).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind Randomized Placebo-Controlled Trial to Evaluate the Efficacy of the "Атопик Soothing Cream" in Children With Mild to Moderate Atopic Dermatitis
Actual Study Start Date : December 29, 2016
Actual Primary Completion Date : May 1, 2017
Actual Study Completion Date : May 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Active Comparator: "Атопик" phase 1
For the first phase of the study, subjects will be randomized to receive treatment with "Атопик Soothing Cream".
Device: "Атопик Soothing Cream"
Topical application of a study cream to involved skin areas twice a day.

Device: Placebo
Topical application of a study placebo cream to involved skin areas twice a day.

Placebo Comparator: Placebo - phase 1
For the first phase of the study, subjects will be randomized to receive treatment with Placebo Cream.
Device: "Атопик Soothing Cream"
Topical application of a study cream to involved skin areas twice a day.

Device: Placebo
Topical application of a study placebo cream to involved skin areas twice a day.

Active Comparator: "Атопик" phase 2
The second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream".
Device: "Атопик Soothing Cream"
Topical application of a study cream to involved skin areas twice a day.

Device: Placebo
Topical application of a study placebo cream to involved skin areas twice a day.

Placebo Comparator: Placebo - phase 2
The second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream".
Device: "Атопик Soothing Cream"
Topical application of a study cream to involved skin areas twice a day.

Device: Placebo
Topical application of a study placebo cream to involved skin areas twice a day.




Primary Outcome Measures :
  1. Investigators' Global Assessment score [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Eczema Area & Severity Index (EASI) [ Time Frame: 28 days ]
  2. Pruritus intensity [ Time Frame: 28 days ]
    Visual Analog Scale


Other Outcome Measures:
  1. Trans-Epidermal Water Loss [ Time Frame: 28 days ]
  2. Stratum Corneum Capacitance [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have clinical diagnosis of mild to moderate atopic dermatitis (AD) at both Screening and Baseline Visits, defined as IGA score of 2 or 3 ( Rothe 1996) or EASI score between 2 and 21 (Leshem 2015)
  • 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 topical corticosteroids within 7 days prior to Baseline
  • 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

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): NCT02716181


Locations
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Russian Federation
Pediatric Allergy-Immunology, Department of Pediatrics, Institute of Professional Education
Samara, Russian Federation
Sponsors and Collaborators
Avanta Trading Ltd.
Samara State Medical University
Prof. Zvulunov Alex, Pediatric Dermatology Clinic, Kfar-Saba, Israel.
Investigators
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Study Director: Alex Zvulunov, MD Prof. Alex Zvulunov, Pediatric Dermatology Clinic, Israel
Publications of Results:
Other Publications:
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Responsible Party: Avanta Trading Ltd.
ClinicalTrials.gov Identifier: NCT02716181    
Other Study ID Numbers: 166-2015
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Clinical parameters at the entry and at the end of study might be shared.
Keywords provided by Avanta Trading Ltd.:
Atopic Dermatitis
Topical therapy
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases