Atopic Dermatitis (AD) is a chronic inflammatory pruritic skin disease that is often associated with other atopic disorders, such as allergic rhinitis and asthma . AD is characterised by poorly defined erythema with oedema, vesiculation, weeping in the acute stage, and skin thickening (lichenification) in the chronic stage .
The prevalence of AD has risen substantially in many countries in recent decades. AD not only leads to a low quality of life, but it also causes depression. AD affects the patients as well as their parents and other family members as well . Therefore, the socioeconomic cost of AD is increasing. In Korea, the total number of people who visit the hospital for AD is 1,035,680 (57th of total 500 disease), and the total was 62,381,288,330 Won in 2010. In addition to the medical market for AD treatments, there is also an enormous cosmetic market totalling approximately 100 billion Won.
The existing treatments for treat AD include topical corticosteroids, emollients, topical tacrolimus, topical 1% pimecrolimus, oral antihistamines, refined-coal tar, topical doxepin and oral corticosteroids. However, these treatments can cause adverse reactions, such as stinging, burning, drowsiness, itching, dyspepsia and hypertension.
Therefore, a demand for novel treatments exists, and functional foods made from natural products have received considerable attention due to the perception that they have no adverse effects .
KM110329 is compound found in Rubi Fructus, Houttuyniae Herba, Rehmanniae Radix, and Betulae Platyphyllae Cortex.
According to herbology textbooks and the World Health Organization (WHO) glossary, the Korean medicinal efficacies of each component of KM110329 are as follows [4, 5].
The effects of Rubi Fructus are to tonify the kidney, to secure its essence and to reduce urination. Rubi Fructus works as a treatment for insufficient consolidation due to kidney deficiency, and it also has beneficial effects on the skin.
Houttuyniae Herba has the function of clearing away heat, detoxifying the body, dissolving boils and draining pus. As a home remedy, it is used to treat furuncle.
Rehmanniae Radix clears heat, engenders fluid, cools the blood to stop bleeding and treats agitation, thirst and skin irritation caused by heat.
Betulae Platyphyllae Cortex mitigates pruritus and skin pain by clearing heat, draining dampness, dispelling phlegm and suppressing cough, dispersing swelling, and detoxifying the body.
Some studies have reported the components of KM110329 have effect on atopic dermatitis. Recent studies suggests that Rubi fructus regulates anaphylaxis and have anti-inflammatory effect [6, 7]. Rehmanniae Radix prevents skin allergic reaction and treats allergen-induced atopic dermatitis in mice by suppressing the expression of cytokines, chemokines and adhesion molecules [8, 9]. Houttuyniae Herba suppresses Th2 immune response and regulates inflammatory process [10, 11]. Betulae Platyphyllae Cortex inhibits the development of atopic dermatitis-like skin lesions in NC/Nga mice through the suppression of the Th2 cell response. It also attenuates mast cell-mediated allergic inflammation in vivo and in vitro [12, 13].
The aim of the present study is to determine the clinical efficacy and safety of KM110329 for AD.
We will conduct a randomised, double-blind, placebo-controlled, multicentre trial of KM110329 in adult patients with AD. Because of the absence of a gold standard for the treatment of AD, this trial will be conducted to determine the effectiveness of this functional food in comparison with a placebo-controlled group.