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

January 9, 2018 updated by: Avanta Trading Ltd.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Samara, Russian Federation
        • Pediatric Allergy-Immunology, Department of Pediatrics, Institute of Professional Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Investigators' Global Assessment score
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eczema Area & Severity Index (EASI)
Time Frame: 28 days
28 days
Pruritus intensity
Time Frame: 28 days
Visual Analog Scale
28 days

Other Outcome Measures

Outcome Measure
Time Frame
Trans-Epidermal Water Loss
Time Frame: 28 days
28 days
Stratum Corneum Capacitance
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avanta Trading Ltd.

Collaborators

Samara State Medical University
Prof. Zvulunov Alex, Pediatric Dermatology Clinic, Kfar-Saba, Israel.

Investigators

  • Study Director: Alex Zvulunov, MD, Prof. Alex Zvulunov, Pediatric Dermatology Clinic, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

March 13, 2016

First Submitted That Met QC Criteria

March 17, 2016

First Posted (Estimate)

March 23, 2016

Study Record Updates

Last Update Posted (Actual)

January 11, 2018

Last Update Submitted That Met QC Criteria

January 9, 2018

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 166-2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Clinical parameters at the entry and at the end of study might be shared.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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