Comparison Study With E-DO in Chronic Hand Dermatitis

NCT00556855 | Completed

• 1 other identifier: EDO-CHD001
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Hand Dermatitis

Keywords

chronic hand dermatitis; research study; E-do; HK-03

Outcome Measures

Primary Outcomes (1)

• The therapeutic response rate (clear or almost clear) base on Investigator Global Assessment (IGA)

  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)

  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.

  during 4 Weeks

• The change of pruritus score and pain score from baseline to post-treatment

  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.

  End of study (4 weeks)

• The safety and tolerability of E-DO including AE/SAE report

  during 4 weeks

Study Arms (2)

A

EXPERIMENTAL

applied on one hand

Other: E-DO

B

PLACEBO COMPARATOR

applied on the other hand

Other: Placebo

Interventions

E-DO OTHER

topical lotion, once daily (evening), total duration: 4 weeks

Also known as: HK-03

A

Placebo OTHER

topical lotion, once daily (evening), total duration: 4 weeks

Also known as: Vehicle

B

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HenKan Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Department of Dermatology, NTUH

Taipei, 100, Taiwan

Location

Study Officials

• Chia-Yu Chu, MD, PhD

  Department of Dermatology, Nation Taiwan University Hopital, R.O.C.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 8, 2007
• First Posted: November 12, 2007
• Study Start: December 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: January 12, 2009

Record last verified: 2009-01

Locations

TW (1)