Ignite Creation Date:
2024-05-06 @ 3:47 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02379507
Status:
COMPLETED
Last Update Posted:
2015-03-05
First Post:
2015-01-13
Brief Title:
DEC033 Study Product for Mild to Moderate Eczema An Open-label Adaptive-design Pilot Study
Sponsor:
Medicus Research LLC
Organization:
Medicus Research LLC
Study Overview
Official Title:
DEC033 Study Product for Mild to Moderate Eczema An Open-label Adaptive-design Pilot Study
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None