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| Name | Class |
|---|---|
| PharmaEssentia Japan K.K. | INDUSTRY |
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Skin Irritation and Phototoxicity Study of KX01 Ointment 1% in Japanese healthy male subjects
A baseline evaluation of the patch sites will be performed immediately prior to application of the patches to ensure that no conditions, markings, or coloration of the skin will interfere with interpretation of the study results.
A total of 4 application sites (2 cm x 2 cm each) will be marked on each subject's back, placing 2 sites for KX01KX2-391 ointment 1% and 2 sites for Placebo vehicle ointment. One set (KX01 ointment 1% IP and Placebo ointment vehicle patches) will be designated for irradiation and the other set will remain non-irradiated under open conditions. The distance between the patches will be no less than one centimeter.
The numbering of the test sites will remain the same throughout the study. The sites will be marked with an indelible, surgical marker.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KX01 ointment and Placebo ointment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KX01 ointment 1% | Drug | A total of 4 application sites (2 cm x 2 cm each) will be marked on each subject's back, placing 2 sites for KX01 ointment 1% and 2 sites for Placebo ointment. One set (KX01 ointment 1% and Placebo ointment patches) will be designated for irradiation and the other set will remain non-irradiated under open conditions. |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of skin irritation at application site | Degree of skin irritation will be evaluated according to the criteria (response scores and response notations). The same evaluator, if possible, should perform the assessment throughout the study. | 9 days |
| Phototoxic potential at application site | Phototoxic potential will be evaluated according to the criteria (response scores and response notations). The same evaluator, if possible, should perform the assessment throughout the study. | 9 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety | 9 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hisakuni Sekino | Medical Corporation HOUEIKAI, Sekino Clinical Pharmacology Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Corporation HOUEIKAI, Sekino Clinical Pharmacology Clinic | Toshima-ku | Tokyo | 171-0014 | Japan |
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| ID | Term |
|---|---|
| D017484 | Dermatitis, Phototoxic |
| ID | Term |
|---|---|
| D017453 | Dermatitis, Irritant |
| D003877 | Dermatitis, Contact |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
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Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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| Placebo ointment | Drug | A total of 4 application sites (2 cm x 2 cm each) will be marked on each subject's back, placing 2 sites for KX01 ointment 1% and 2 sites for Placebo ointment. One set (KX01 ointment 1% and Placebo ointment patches) will be designated for irradiation and the other set will remain non-irradiated under open conditions. |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D010787 | Photosensitivity Disorders |
| D017443 | Skin Diseases, Eczematous |