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

Study Overview
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Brief Summary
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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
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Atopic Dermatitis

Intervention / Treatment
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* Device: KAM2904 Face Cream
* Device: KAM3008 Body Lotion
* Other: petrolatum-based moisturizer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Trend in the change of SCORAD |  | after 42 days of treatment | 
| • Trend in the change of EASI |  | after 42 days of treatment | 
| • Trend in the change of individual symptoms of atopic dermatitis |  | after 42 days of treatment | 
| • 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 |