Clinical trial NCT01781663: Efficacy of KAM2904 Face Cream and KAM3008 Body Lotion Treatment in Children With Atopic Dermatitis (AD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atopic Dermatitis
Lead sponsor: Kamedis Ltd.
Sponsor class: INDUSTRY
First posted: 2013-02-01
Enrollment: 56
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: • Change in SCORAD (Scoring Atopic Dermatitis)
timeFrame: after 42 days of treatment
measure: • Change in EASI (Eczema Area Severity Index)
timeFrame: after 42 days of treatment
measure: • Change in the scoring of individual symptoms of atopic dermatitis
timeFrame: after 42 days of treatment
Secondary outcomes:
measure: • Trend in the change of SCORAD
timeFrame: after 42 days of treatment
measure: • Trend in the change of EASI
timeFrame: after 42 days of treatment
measure: • Trend in the change of individual symptoms of atopic dermatitis
timeFrame: after 42 days of treatment
measure: • Safety of KAM2904 Face Cream and KAM3008 Body Lotion
timeFrame: days D14, D28, D42 and unscheduled visits
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fundación Teknon
Study officials:
affiliation: Tel Aviv Soraski Medical Center - Dermatology Unit
name: Prof. Eli Sprecher, MD
role: PRINCIPAL_INVESTIGATOR
References: