Back to resultsEfficacy of the "Атопик Soothing Cream" in Children With Mild to Moderate Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
"Атопик Soothing Cream"
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, Topical therapy
Eligibility 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
Sites / Locations
- Pediatric Allergy-Immunology, Department of Pediatrics, Institute of Professional Education
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Arm Label
"Атопик" phase 1
Placebo - phase 1
"Атопик" phase 2
Placebo - phase 2
Arm Description
For the first phase of the study, subjects will be randomized to receive treatment with "Атопик Soothing Cream".
For the first phase of the study, subjects will be randomized to receive treatment with Placebo Cream.
The second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream".
The second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream".
Outcomes
Primary Outcome Measures
Investigators' Global Assessment score
Secondary Outcome Measures
Eczema Area & Severity Index (EASI)
Pruritus intensity
Visual Analog Scale
Full Information
NCT ID
NCT02716181
First Posted
March 13, 2016
Last Updated
January 9, 2018
Sponsor
Avanta Trading Ltd.
Collaborators
Samara State Medical University, Prof. Zvulunov Alex, Pediatric Dermatology Clinic, Kfar-Saba, Israel.
1. Study Identification
Unique Protocol Identification Number
NCT02716181
Brief Title
Efficacy of the "Атопик Soothing Cream" in Children With Mild to Moderate Atopic Dermatitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
December 29, 2016 (Actual)
Primary Completion Date
May 1, 2017 (Actual)
Study Completion Date
May 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avanta Trading Ltd.
Collaborators
Samara State Medical University, Prof. Zvulunov Alex, Pediatric Dermatology Clinic, Kfar-Saba, Israel.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic Dermatitis, Topical therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
"Атопик" phase 1
Arm Type
Active Comparator
Arm Description
For the first phase of the study, subjects will be randomized to receive treatment with "Атопик Soothing Cream".
Arm Title
Placebo - phase 1
Arm Type
Placebo Comparator
Arm Description
For the first phase of the study, subjects will be randomized to receive treatment with Placebo Cream.
Arm Title
"Атопик" phase 2
Arm Type
Active Comparator
Arm Description
The second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream".
Arm Title
Placebo - phase 2
Arm Type
Placebo Comparator
Arm Description
The second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream".
Intervention Type
Device
Intervention Name(s)
"Атопик Soothing Cream"
Intervention Description
Topical application of a study cream to involved skin areas twice a day.
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
Topical application of a study placebo cream to involved skin areas twice a day.
Primary Outcome Measure Information:
Title
Investigators' Global Assessment score
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Eczema Area & Severity Index (EASI)
Time Frame
28 days
Title
Pruritus intensity
Description
Visual Analog Scale
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
Trans-Epidermal Water Loss
Time Frame
28 days
Title
Stratum Corneum Capacitance
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Zvulunov, MD
Organizational Affiliation
Prof. Alex Zvulunov, Pediatric Dermatology Clinic, Israel
Official's Role
Study Director
Facility Information:
Facility Name
Pediatric Allergy-Immunology, Department of Pediatrics, Institute of Professional Education
City
Samara
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Clinical parameters at the entry and at the end of study might be shared.
Citations:
PubMed Identifier
24894548
Citation
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.
Results Reference
background
PubMed Identifier
12113650
Citation
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.
Results Reference
background
PubMed Identifier
25345257
Citation
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.
Results Reference
result
Learn more about this trial
Efficacy of the "Атопик Soothing Cream" in Children With Mild to Moderate Atopic Dermatitis
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