Chronic Hand DermatitisNCT00556855
Comparison Study With E-DO in Chronic Hand Dermatitis
A study testing E-DO in people with Chronic Hand Dermatitis, run by HenKan Pharmaceutical Co., Ltd. at 1 site in Taiwan.
Trial summary
The objective of this study is to evaluate the topical E-DO in patients with Chronic Hand Dermatitis (fu kuei shou). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Hand Dermatitis
- What is being tested?
- E-DO
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2007to Jul 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 4-Week Randomized, Double-Blind, Placebo-Controlled, Right-Left Comparison Study With E-DO in Chronic Hand Dermatitis
The objective of this study is to evaluate the topical E-DO in patients with Chronic Hand Dermatitis (fu kuei shou).
Read the 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.
- Conditions
- Chronic Hand Dermatitis
- Being tested
- E-DO, Placebo
- Keywords
- chronic hand dermatitis, research study, E-do, HK-03
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-DOOther
Also called HK-03
topical lotion, once daily (evening), total duration: 4 weeks
PlaceboOther
Also called Vehicle
topical lotion, once daily (evening), total duration: 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | applied on one hand Receives: Other: E-DO |
| B | Placebo comparator | applied on the other hand Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The therapeutic response rate (clear or almost clear) base on Investigator Global Assessment (IGA)
Measured: at Week 4 (or at time of early discontinuation)
Secondary outcomes (5)
The proportion of the patients with at least 50% improvement (clinically significant response) base on the patient's global assessment (PaGA)
Measured: at Week 4 (or at time of early discontinuation)
The percent change in the HEAS (Hand Eczema Area and Severity Score) from baseline to post-treatment.
Measured: during 4 Weeks
The change of pruritus score and pain score from baseline to post-treatment
Measured: during 4 weeks
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.
Measured: End of study (4 weeks)
The safety and tolerability of E-DO including AE/SAE report
Measured: during 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startDec 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hand DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- HenKan Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Chia-Yu Chu, MD, PhD, Principal investigator, Department of Dermatology, Nation Taiwan University Hopital, R.O.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556855
- Sponsor's protocol ID
- EDO-CHD001
- Status last verified
- Jan 2009
- First submitted
- 8 Nov 2007
- Last updated
- 12 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-Week Randomized, Double-Blind, Placebo-Controlled, Right-Left Comparison Study With E-DO in Chronic Hand Dermatitis
- ClinicalTrials.gov ID
- NCT00556855
- Acronym / sponsor ID
- EDO-CHD001
- Conditions
- Chronic Hand Dermatitis
- Keywords
- chronic hand dermatitis, research study, E-do, HK-03
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- HenKan Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 12 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the topical E-DO in patients with Chronic Hand Dermatitis (fu kuei shou).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: E-DOapplied on one hand |
| B | Placebo comparator | Other: Placeboapplied on the other hand |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-DOAlso: HK-03topical lotion, once daily (evening), total duration: 4 weeks | Other | A |
| PlaceboAlso: Vehicletopical lotion, once daily (evening), total duration: 4 weeks | Other | B |
Primary outcome
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)
5 secondary outcomes
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)
The percent change in the HEAS (Hand Eczema Area and Severity Score) from baseline to post-treatment.
Time frame: during 4 Weeks
The change of pruritus score and pain score from baseline to post-treatment
Time frame: during 4 weeks
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)
The safety and tolerability of E-DO including AE/SAE report
Time frame: during 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Yu Chu, MD, PhD principal investigator
Department of Dermatology, Nation Taiwan University Hopital, R.O.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-DO in people with Chronic Hand Dermatitis, run by HenKan Pharmaceutical Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2009.