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

Kamedis

Status and phase: Unknown; Phase 4

Conditions: Atopic Dermatitis

Treatments: Device: KAM2904 Face Cream; Device: KAM3008 Body Lotion; Other: petrolatum-based moisturizer

Study type: Interventional

Funder types: Industry

Identifiers

NCT01781663

KAM-ATOPIC-01

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups

KAM2904 Face Cream and KAM3008 Body Lotion

Experimental group

Description:

A group treated with KAM2904 Face Cream and KAM3008 Body Lotion

Treatment:

Device: KAM3008 Body Lotion

Device: KAM2904 Face Cream

petrolatum-based moisturizer

Sham Comparator group

Description:

control group

Treatment:

Other: petrolatum-based moisturizer