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| Name | Class |
|---|---|
| Dr. Cheung Hing Cheong Private Dermatology Clinic | UNKNOWN |
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This is a study of hygienic socks with antifungal agent-loaded microcapsules for subjects with interdigital type tinea pedis (athlete's foot between the toes). This is a 6 week study which has a 2 week treatment period and a 4 week follow-up evaluation.
Tinea pedis (Athlete's Foot) is a common skin disease which affects a large number of the population. The development of hygienic socks through the microencapsulation technology have great potential to provide the convenient pharmacological treatment on one hand, and good moisture management which can reduce the microbial overgrowth on the other hand for patients with tinea pedis. The socks, therefore, reduce the effects of the skin disease on the quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug loaded microcapsules socks | Experimental | Study medication |
|
| No drug loaded microcapsules socks | Placebo Comparator | Placebo medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-fungal agent (Clotrimazole) loaded microcapsules | Drug | Clotrimazole loaded microcapsules padded on socks and the patient should wear the socks every day for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| • Complete Cure | Complete Cure is defined as a negative KOH and negative fungal culture and no evidence of clinical disease for each sign and symptom at Day 44. | Day 44 |
| Measure | Description | Time Frame |
|---|---|---|
| Effective Treatment | Effective Treatment defined as negative KOH, negative fungal culture, no or mild erythema and/or scaling with all other signs or symptoms being absent at Day 44. | Day 44 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chun Wah M. Yuen | Hong Kong PU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Textiles and Clothing, The Hong Kong Polytechnic University | Kowloon | 00852 | Hong Kong |
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| ID | Term |
|---|---|
| D014008 | Tinea Pedis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D003022 | Clotrimazole |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Placebo | Drug | No drug loaded microcapsules socks |
|
| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D005533 | Foot Dermatoses |
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011537 | Pruritus |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |