NCT02716181

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

December 29, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

January 11, 2018

Status Verified

March 1, 2016

Enrollment Period

4 months

First QC Date

March 13, 2016

Last Update Submit

January 9, 2018

Conditions

Atopic Dermatitis

Keywords

Atopic DermatitisTopical therapy

Outcome Measures

Primary Outcomes (1)

  • Investigators' Global Assessment score

    28 days

Secondary Outcomes (2)

  • Eczema Area & Severity Index (EASI)

    28 days

  • Pruritus intensity

    28 days

Other Outcomes (2)

  • Trans-Epidermal Water Loss

    28 days

  • Stratum Corneum Capacitance

    28 days

Study Arms (4)

"Атопик" phase 1

ACTIVE COMPARATOR

For the first phase of the study, subjects will be randomized to receive treatment with "Атопик Soothing Cream".

Device: "Атопик Soothing Cream"Device: Placebo

Placebo - phase 1

PLACEBO COMPARATOR

For the first phase of the study, subjects will be randomized to receive treatment with Placebo Cream.

Device: "Атопик Soothing Cream"Device: Placebo

"Атопик" phase 2

ACTIVE COMPARATOR

The second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream".

Device: "Атопик Soothing Cream"Device: Placebo

Placebo - phase 2

PLACEBO COMPARATOR

The second phase of the study is an open-label extension with all subjects receiving "Атопик Soothing Cream".

Device: "Атопик Soothing Cream"Device: Placebo

Interventions

"Атопик Soothing Cream"DEVICE

Topical application of a study cream to involved skin areas twice a day.

"Атопик" phase 1"Атопик" phase 2Placebo - phase 1Placebo - phase 2
PlaceboDEVICE

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

"Атопик" phase 1"Атопик" phase 2Placebo - phase 1Placebo - phase 2

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Allergy-Immunology, Department of Pediatrics, Institute of Professional Education

Samara, Russia

Location

Related Publications (3)

  • 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.

    PMID: 24894548BACKGROUND

  • 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.

    PMID: 12113650BACKGROUND

  • 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.

    PMID: 25345257RESULT

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Alex Zvulunov, MD

    Prof. Alex Zvulunov, Pediatric Dermatology Clinic, Israel

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2016

First Posted

March 23, 2016

Study Start

December 29, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

January 11, 2018

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will share

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

Locations

RU(1)