DEC033 Study Product for Mild to Moderate Eczema An Open-label, Adaptive-design Pilot Study
Condition: Eczema
MeSH terms: Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, adaptive design study was designed to determine the efficacy of the study
      product in the treatment of eczema which would be assessed by the reduction of the appearance
      of skin lesions and symptoms associated such as itching, scaling and redness.
    

Detailed description: 
      Eczema is an inflammatory skin disease characterized by itchy red rashes commonly found in
      the elbows or behind the knees. Eczema lesions may appear as collection of fluid in the skin
      (vesicles) or as gross thickening of the skin (lichenification) with redness. It is also
      associated with crusting, scaling, cracking, and swelling of the skin. Usually, it does not
      need medical treatment. However, a more severe form of eczema is referred to as atopic eczema
      or atopic dermatitis which occurs in childhood or early adulthood. The overall prevalence of
      this condition in Northern Europe is 15-20% of children aged 7-18 years. Atopic eczema
      greatly affects the quality of life of the individuals and in fact accounts for the highest
      scores when compared with other dermatological diseases. A child with eczema experiences itch
      and sleep disturbances, ostracism by other children, the need for special clothing and
      bedding, avoidance of physical activities such as swimming and the need for frequent
      application of ointments.

      Eczema is commonly treated with antihistamine pills and creams or ointments. Antihistamines
      and steroid creams control the itching and rash caused by severe eczema. It is also
      recommended that the skin be well lubricated to prevent it from becoming dry. A systematic
      review of randomized clinical trials on atopic eczema summarized the interventions for
      treating the condition which include pharmacological drug type (topical steroids), similar
      intervention type (dietary measures) or convenience (non-pharmacological treatments).

      Shea butter, which contains stearic acid, linoleic acid, and catechins (antioxidants), is
      processed from nut of the Vitellaria paradoxa tree. It is traditionally used as lotion for
      the skin and hair as it is considered an emollient and skin conditioning agent. It has also
      been of importance in soothing arthritic pains, reducing swelling, treating skin problems,
      and as antiseptic for wounds. Shea butter is also found in topical formulations used for
      inflammatory dermatoses such as psoriasis and atopic dermatitis. Shea butter consists of
      triterpene cinnamates and acetates and these were found to have anti-inflammatory activity
      which can help in the reduction of edema associated with eczema. Human clinical studies have
      demonstrated shea butter as skin aging treatment which regenerates skin and gives smoother,
      clearer skin. Wrinkles from photoaging were also diminished. Another trial showed that shea
      butter has cicatrizing action in 70% of cases of hand dermatitis, sun burns and scars. A
      cream with shea butter was also demonstrated to promote good moisturization of the skin
      compared to placebo.

      Macadamia nut oil is one of the most heart-friendly oils. It contains vitamin E, omega-3,
      omega-6, oleic, linoleic, and palmitoleic acids. Macadamia oil decreases low density
      lipoprotein levels and increases high density lipoprotein levels thus reducing risk of heart
      diseases. There are various benefits of macadamia oil on skin. It provides moisturization and
      anti-aging effects. Palmitoleic acid, which is commonly found in the skin, decreases as
      people age. Macadamia oil helps replace the lost compound to maintain youthful skin.
      Blemishes and scars are also removed with the help of macadamia oil. It has anti-inflammatory
      activity and antioxidant effects thus reducing free radicals on the skin and providing
      healing of skin conditions such as sunburns.

      This open-label, adaptive design study was designed to determine the efficacy of the study
      product in the treatment of eczema which would be assessed by the reduction of the appearance
      of skin lesions and symptoms associated such as itching, scaling and redness.
    

Intervention name(s): DEC033 Study Product
Intervention type(s): Other
Intervention description(s): Apply twice daily
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: mild to moderate