DEC033 Study Product for Mild to Moderate Eczema An Open-label, Adaptive-design Pilot Study
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|ClinicalTrials.gov Identifier: NCT02379507|
Recruitment Status : Completed
First Posted : March 5, 2015
Last Update Posted : March 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Eczema||Other: DEC033 Study Product||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||DEC033 Study Product for Mild to Moderate Eczema An Open-label, Adaptive-design Pilot Study|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Experimental: DEC033 Study Product
Apply twice a day
Other: DEC033 Study Product
Apply twice daily
- Symptoms of Itching, Scaling, and Redness measured by Visual Analog Scale (VAS) [ Time Frame: 30 days ]Subjects completed the Visual Analog Scale for eczema symptoms - itching, scaling, and redness.
- Size and Severity of Eczema Lesions measured by Dermatologic Assessments [ Time Frame: 30 days ]Dermatologic assessments for severity and size of lesions and Severity Scoring of Atopic Dermatitis (SCORAD) were assessed by a practitioner in the clinic.