Efficacy of KAM2904 Face Cream and KAM3008 Body Lotion Treatment in Children With Atopic Dermatitis (AD)

NCT ID: NCT01781663

Last Updated: 2014-01-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28

Brief Summary

The main purpose of this study is to demonstrate the safety and efficacy of KAM2904 Face Cream and KAM3008 Body Lotion in reducing the symptoms of mild to moderate AD. Efficacy will be evaluated by comparing SCORAD and Eczema Area Severity Index (EASI) in a group of subjects treated with KAM2904 Face Cream and KAM3008 Body Lotion (the treatment group), versus a group of subjects treated with a petrolatum-based moisturizer (the control group). Safety will be determined by the number and severity of Adverse Events Device-Related.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

KAM2904 Face Cream and KAM3008 Body Lotion

A group treated with KAM2904 Face Cream and KAM3008 Body Lotion

Group Type: EXPERIMENTAL

KAM2904 Face Cream

Intervention Type: DEVICE

KAM3008 Body Lotion

Intervention Type: DEVICE

petrolatum-based moisturizer

control group

Group Type: SHAM_COMPARATOR

petrolatum-based moisturizer

Intervention Type: OTHER

Interventions

KAM2904 Face Cream

Intervention Type: DEVICE

KAM3008 Body Lotion

Intervention Type: DEVICE

petrolatum-based moisturizer

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• • Male or female between 2 and 12 years of age

• The subject suffers from moderate atopic dermatitis (SCORAD<40) that is amenable to treatment
• Diagnosis of atopic dermatitis meets Hanifin's criteria (at least 3 basic features and at least 3 minor features)
• Atopic dermatitis is, in the opinion of the investigator, stable for the past 7 days
• The subject's parents are able to apply the study product twice a day (each morning and evening) for a consecutive period of 42 days
• The subject's parents agree that the subject will not change his/her lifestyle during the study period (including: regular body hygiene product (soap), the number of baths and showers per day, the laundry detergent and fabric softener used to wash clothes)
• The subject's parents agree to use only the test product during the study period
• The subject's legal guardian is able and willing to sign the informed consent form and to comply with the study regulations of this protocol

Exclusion Criteria

• • The subject has another dermatological disease/condition that could interfere with the clinical evaluation, including infected atopic dermatitis lesions

• The subject has a previous history of allergy to cosmetic products or to any of the ingredients included in the tested formulations (Appendices 1 and 2)
• The subject received a topical or a systemic immune-modulator (such calcineurin inhibitors or cortico-steroids) for the treatment of atopic dermatitis, within 14 days prior to day 0
• The subject underwent phototherapy within 28 days prior to day 0
• The subject is expected to be extensively exposed to the sun during the trial
• The subject underwent any experimental treatment within 14 days prior to day 0

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kamedis Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. Eli Sprecher, MD

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Soraski Medical Center - Dermatology Unit

Locations

Fundación Teknon

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Miri Sani

Role: CONTACT

mirisani@013.net

Facility Contacts

Dr. Carlos Marin, MD

Role: primary

Related Links

http://www.kamedis.com

Sponsor's site

Other Identifiers

KAM-ATOPIC-01

Identifier Type: -

Identifier Source: org_study_id