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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Kamedis Ltd.
Sponsor:
Information provided by (Responsible Party):
Kamedis Ltd.
ClinicalTrials.gov Identifier:
NCT01781663
First received: January 29, 2013
Last updated: January 29, 2014
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
Device: KAM2904 Face Cream
Device: KAM3008 Body Lotion
Other: petrolatum-based moisturizer
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Kamedis Ltd.:

Primary Outcome Measures:
  • • Change in SCORAD (Scoring Atopic Dermatitis) [ Time Frame: after 42 days of treatment ] [ Designated as safety issue: No ]
  • • Change in EASI (Eczema Area Severity Index) [ Time Frame: after 42 days of treatment ] [ Designated as safety issue: No ]
  • • Change in the scoring of individual symptoms of atopic dermatitis [ Time Frame: after 42 days of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • Trend in the change of SCORAD [ Time Frame: after 42 days of treatment ] [ Designated as safety issue: No ]
  • • Trend in the change of EASI [ Time Frame: after 42 days of treatment ] [ Designated as safety issue: No ]
  • • Trend in the change of individual symptoms of atopic dermatitis [ Time Frame: after 42 days of treatment ] [ Designated as safety issue: No ]
  • • Safety of KAM2904 Face Cream and KAM3008 Body Lotion [ Time Frame: days D14, D28, D42 and unscheduled visits ] [ Designated as safety issue: Yes ]
    Safety will be measured by the number and severity of Device-Related Adverse Events.


Estimated Enrollment: 56
Study Start Date: February 2013
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781663

Contacts
Contact: Miri Sani mirisani@013.net

Locations
Spain
Fundación Teknon Recruiting
Barcelona, Spain
Contact: Dr. Carlos Marin, MD         
Principal Investigator: Dr. Carlos Marin, MD         
Sponsors and Collaborators
Kamedis Ltd.
Investigators
Principal Investigator: Prof. Eli Sprecher, MD Tel Aviv Soraski Medical Center - Dermatology Unit
  More Information

Additional Information:
No publications provided

Responsible Party: Kamedis Ltd.
ClinicalTrials.gov Identifier: NCT01781663     History of Changes
Other Study ID Numbers: KAM-ATOPIC-01
Study First Received: January 29, 2013
Last Updated: January 29, 2014
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Petrolatum
Emollients
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014