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

This is an interventional treatment trial for Atopic Dermatitis Read More

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