Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
67 participants
INTERVENTIONAL
2007-12-31
2008-07-31
Brief Summary
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Detailed Description
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Primary treatment for hand dermatitis is typically topical corticosteroids, especially when the offending agent(s) cannot be identified or avoided. However, patients may eventually develop tachyphylaxis to the anti-inflammatory activity of mid-potency or high-potency topical corticosteroids and patients with severe, chronic involvement may often be less likely to respond. Potential topical alternatives to corticosteroids include psoralen plus ultraviolet (PUVA), but the phototherapies are inconvenient because multiple clinical visits are required and hand phototherapy units may not be available.
Moisturizers have been found to help restore the skin barrier providing a protective layer on surface of the skin to trap water and prevent the penetration of irritants and allergens. An emollient cream is superior in trapping the moisture within the skin. Emollients may form a covering film, which acts as a barrier for chemicals from the exterior and which restricts the loss of water and other essential substances from the interior. E-DO gel is a potential agent for revitalizing our skin cells so that regain their moisture retention capacity.
E-DO has known significant improvements in wound healing and the inhibition of Staphylococcus aureus and Propionibacterium acnes. This pilot research trial will investigate the effect of topical E-DO for patients with hand dermatitis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
applied on one hand
E-DO
topical lotion, once daily (evening), total duration: 4 weeks
B
applied on the other hand
Placebo
topical lotion, once daily (evening), total duration: 4 weeks
Interventions
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E-DO
topical lotion, once daily (evening), total duration: 4 weeks
Placebo
topical lotion, once daily (evening), total duration: 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have chronic hand dermatitis based upon clinical diagnosis at least mild dermatitis of the both hands at baseline, as defined by an Investigator Global Assessment score of 2 (mild) to 5 (very severe);
* Patients must have been informed of the study procedures and therapies and have given their written informed consent.
Exclusion Criteria
* Patients who have received systemic corticosteroids (i.e., oral, intravenous, intra-articular, rectal, intramuscular) within one month prior to first application of study medication;
* Patients who have received phototherapy (e.g., UVB, PUVA) or systemic therapy (e.g., immunosuppressants, cytostatics) known or suspected to have an effect on hand dermatitis within one month prior to first application of study medication;
* Patients who are treated with topical therapy (e.g., tar, topical corticosteroids) known or suspected to have an effect on hand dermatitis within 7 days prior to first application of study medication;
* Patients who have a diagnosis on the hands of active atopic dermatitis, dyshidrotic eczema, psoriasis, urticaria, active fungal or bacterial infection, or identified allergic contact dermatitis (e.g., poison ivy dermatitis)
* Patients with hypersensitivity to vitamin B, vitamin C, vitamin E, beta-carotene.
20 Years
ALL
No
Sponsors
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HenKan Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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HenKan Pharmaceutical Co., Ltd.
Principal Investigators
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Chia-Yu Chu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Dermatology, Nation Taiwan University Hopital, R.O.C.
Locations
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Department of Dermatology, NTUH
Taipei, , Taiwan
Countries
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Other Identifiers
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EDO-CHD001
Identifier Type: -
Identifier Source: org_study_id
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