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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
Fundación Teknon
Barcelona, Spain
RECRUITING• Change in SCORAD (Scoring Atopic Dermatitis)
Time frame: after 42 days of treatment
• Change in EASI (Eczema Area Severity Index)
Time frame: after 42 days of treatment
• Change in the scoring of individual symptoms of atopic dermatitis
Time frame: after 42 days of treatment
• Trend in the change of SCORAD
Time frame: after 42 days of treatment
• Trend in the change of EASI
Time frame: after 42 days of treatment
• Trend in the change of individual symptoms of atopic dermatitis
Time frame: 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.
Time frame: days D14, D28, D42 and unscheduled visits
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.