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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02716181
• Other study ID #: 166-2015
• Status: Completed
• Phase: N/A
• First received: March 13, 2016
• Last updated: January 9, 2018
• Start date: December 29, 2016
• Est. completion date: May 1, 2017

Study information

• Verified date: March 2016
• Source: Avanta Trading Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Device:
• "?????? 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.

Locations

Country	Name	City	State
Russian Federation	Pediatric Allergy-Immunology, Department of Pediatrics, Institute of Professional Education	Samara

Sponsors (3)

Lead Sponsor	Collaborator
Avanta Trading Ltd.	Prof. Zvulunov Alex, Pediatric Dermatology Clinic, Kfar-Saba, Israel., Samara State Medical University, Samara, Russian Federation

Country where clinical trial is conducted

Russian Federation, 

References & Publications (3)

Ebner F, Heller A, Rippke F, Tausch I. Topical use of dexpanthenol in skin disorders. Am J Clin Dermatol. 2002;3(6):427-33. Review. — View 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 — View Citation

Maurya AK, Singh M, Dubey V, Srivastava S, Luqman S, Bawankule DU. a-(-)-bisabolol reduces pro-inflammatory cytokine production and ameliorates skin inflammation. Curr Pharm Biotechnol. 2014;15(2):173-81. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Trans-Epidermal Water Loss		28 days
Other	Stratum Corneum Capacitance		28 days
Primary	Investigators' Global Assessment score		28 days
Secondary	Eczema Area & Severity Index (EASI)		28 days
Secondary	Pruritus intensity	Visual Analog Scale	28 days