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

January 29, 2014 updated by: Kamedis Ltd.
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain
        • Recruiting
        • Fundacion Teknon
        • Contact:
          • Dr. Carlos Marin, MD
        • Principal Investigator:
          • Dr. Carlos Marin, MD

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

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KAM2904 Face Cream and KAM3008 Body Lotion
A group treated with KAM2904 Face Cream and KAM3008 Body Lotion
Device: KAM2904 Face Cream
Device: KAM3008 Body Lotion
Sham Comparator: petrolatum-based moisturizer
control group
Other: petrolatum-based moisturizer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
• Change in SCORAD (Scoring Atopic Dermatitis)
Time Frame: after 42 days of treatment
after 42 days of treatment
• Change in EASI (Eczema Area Severity Index)
Time Frame: after 42 days of treatment
after 42 days of treatment
• Change in the scoring of individual symptoms of atopic dermatitis
Time Frame: after 42 days of treatment
after 42 days of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• Trend in the change of SCORAD
Time Frame: after 42 days of treatment
after 42 days of treatment
• Trend in the change of EASI
Time Frame: after 42 days of treatment
after 42 days of treatment
• Trend in the change of individual symptoms of atopic dermatitis
Time Frame: after 42 days of treatment
after 42 days of treatment
• Safety of KAM2904 Face Cream and KAM3008 Body Lotion
Time Frame: days D14, D28, D42 and unscheduled visits
Safety will be measured by the number and severity of Device-Related Adverse Events.
days D14, D28, D42 and unscheduled visits

Collaborators and Investigators

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

Sponsor

Kamedis Ltd.

Investigators

  • Principal Investigator: Prof. Eli Sprecher, MD, Tel Aviv Soraski Medical Center - Dermatology Unit

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.

Helpful Links

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

February 1, 2013

Primary Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

January 29, 2013

First Submitted That Met QC Criteria

January 30, 2013

First Posted (Estimate)

February 1, 2013

Study Record Updates

Last Update Posted (Estimate)

January 30, 2014

Last Update Submitted That Met QC Criteria

January 29, 2014

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAM-ATOPIC-01

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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