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Comparison Study With E-DO in Chronic Hand Dermatitis

This study has been completed.
Sponsor:
Information provided by:
HenKan Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00556855
First received: November 8, 2007
Last updated: January 9, 2009
Last verified: January 2009
  Purpose

The objective of this study is to evaluate the topical E-DO in patients with Chronic Hand Dermatitis (fu kuei shou).


Condition Intervention
Chronic Hand Dermatitis
Other: E-DO
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 4-Week Randomized, Double-Blind, Placebo-Controlled, Right-Left Comparison Study With E-DO in Chronic Hand Dermatitis

Further study details as provided by HenKan Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • The therapeutic response rate (clear or almost clear) base on Investigator Global Assessment (IGA) [ Time Frame: at Week 4 (or at time of early discontinuation) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of the patients with at least 50% improvement (clinically significant response) base on the patient's global assessment (PaGA) [ Time Frame: at Week 4 (or at time of early discontinuation) ] [ Designated as safety issue: No ]
  • The percent change in the HEAS (Hand Eczema Area and Severity Score) from baseline to post-treatment. [ Time Frame: during 4 Weeks ] [ Designated as safety issue: No ]
  • The change of pruritus score and pain score from baseline to post-treatment [ Time Frame: during 4 weeks ] [ Designated as safety issue: No ]
  • The change in the degree of moisture on the skin's surface, and the water evaporation on skin surfaces by TEWL, and the QOL scores from baseline to the end of study. [ Time Frame: End of study (4 weeks) ] [ Designated as safety issue: No ]
  • The safety and tolerability of E-DO including AE/SAE report [ Time Frame: during 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 67
Study Start Date: December 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
applied on one hand
Other: E-DO
topical lotion, once daily (evening), total duration: 4 weeks
Other Names:
  • E-DO
  • HK-03
Placebo Comparator: B
applied on the other hand
Other: Placebo
topical lotion, once daily (evening), total duration: 4 weeks
Other Name: Vehicle

Detailed Description:

Hand dermatitis, also called fu kuei shou, is a skin condition in which the hands develop a rash and become red, dry, cracked, and inflamed. This is a very common occuring in about 10% of women and 4% of men. The condition can eventually cause pain on contact with even simple solutions such as water. Hand dermatitis is particularly common in industries involving cleaning, catering, metalwork, hairdressing, healthcare and mechanical work, and is often difficult to be treated effectively. Some patients develop varying levels of disability due to lack of acceptable effective treatments and may be forced to change occupations in order to achieve relief.

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females aged 20 years of age or above;
  • 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:

  • Women who are pregnant or who are breast-feeding;
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556855

Locations
Taiwan
Department of Dermatology, NTUH
Taipei, Taiwan, 100
Sponsors and Collaborators
HenKan Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Chia-Yu Chu, MD, PhD Department of Dermatology, Nation Taiwan University Hopital, R.O.C.
  More Information

No publications provided

Responsible Party: Joseph Tseng, HenKan Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00556855     History of Changes
Other Study ID Numbers: EDO-CHD001
Study First Received: November 8, 2007
Last Updated: January 9, 2009
Health Authority: Taiwan: Department of Health
Taiwan: Research Ethics Committee, NTUH

Keywords provided by HenKan Pharmaceutical Co., Ltd.:
chronic hand dermatitis
research study
E-do
HK-03

Additional relevant MeSH terms:
Dermatitis
Skin Diseases

ClinicalTrials.gov processed this record on November 27, 2014