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The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.
Healthy, adult volunteers of either sex will be patched daily on his/her arm with multiple strengths of PAC-14028 cream, non-active comparator and an active comparator over the course of 21 consecutive days. Twenty-four hours after each application, the Finn-chamber patches will be removed and the site evaluated using a five-point scale for irritation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAC14028-Vehicle | Placebo Comparator | PAC-14028 Cream Vehicle |
|
| PAC14028-0.1 | Experimental | PAC-14028 Cream 0.1% |
|
| PAC14028-0.3 | Experimental | PAC-14028 Cream 0.3% |
|
| PAC14028-1.0 | Experimental | PAC-14028 Cream 1% |
|
| Placebo | Placebo Comparator | Saline |
|
| Positive control | Active Comparator | Sodium Lauryl Sulfate, 0.5% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAC14028-Vehicle | Other | PAC-14028 Cream Vehicle, Daily for up to 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Irritation Score (5-point scale, 0-4) | Daily for 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyu-Han Kim, M.D.,Ph.D. | Seoul National University Hospital, Department of Dermatology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital, Department of Dermatology | Seoul | Seoul | 110-744 | South Korea |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D015870 | Gene Expression |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| PAC14028-0.1 | Drug | PAC-14028 Cream, 0.1%, Daily for up to 21 days |
|
|
| PAC14028-0.3 | Drug | PAC-14028 Cream, 0.3%, Daily for up to 21 days |
|
|
| PAC14028-1.0 | Drug | PAC-14028 Cream, 1%, Daily for up to 21 days |
|
|
| Saline | Other | Saline, Daily for up to 21 days |
|
|
| Positive | Other | Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days |
|
| D017670 |
| Sodium Compounds |
| D055614 | Genetic Phenomena |