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

Atopic Dermatitis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01781663
• Other study ID #: KAM-ATOPIC-01
• Status: Recruiting
• Phase: Phase 4
• First received: January 29, 2013
• Last updated: January 29, 2014
• Start date: February 2013

Study information

• Verified date: July 2013
• Source: Kamedis Ltd.
• Contact: Miri Sani
• Email: mirisani[@]013.net
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Device:
• KAM2904 Face Cream

• KAM3008 Body Lotion

Other:
• petrolatum-based moisturizer

Locations

Country	Name	City	State
Spain	Fundación Teknon	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Kamedis Ltd.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Change in SCORAD (Scoring Atopic Dermatitis)		after 42 days of treatment	No
Primary	• Change in EASI (Eczema Area Severity Index)		after 42 days of treatment	No
Primary	• Change in the scoring of individual symptoms of atopic dermatitis		after 42 days of treatment	No
Secondary	• Trend in the change of SCORAD		after 42 days of treatment	No
Secondary	• Trend in the change of EASI		after 42 days of treatment	No
Secondary	• Trend in the change of individual symptoms of atopic dermatitis		after 42 days of treatment	No
Secondary	• Safety of KAM2904 Face Cream and KAM3008 Body Lotion	Safety will be measured by the number and severity of Device-Related Adverse Events.	days D14, D28, D42 and unscheduled visits	Yes

External Links

•   Sponsor's site