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This study will evaluate the pharmacokinetics and safety of ALA in patients with moderate and severe acne vulgaris after single dose in different dosages.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose | Experimental |
| |
| High dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALA 5% | Drug | prepare 5% ALA solution, apply topically to the affected area for 1.5 hours, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration [Cmax] | pharmacokinetic parameter | 24 hours postdose |
| Area Under the Curve [AUC] | pharmacokinetic parameter | 24 hours postdose |
| Tmax | pharmacokinetic parameter | 24 hours postdose |
| Half-life Time [T1/2] | pharmacokinetic parameter | 24 hours postdose |
| Clearance [CL] | pharmacokinetic parameter | 24 hours postdose |
| Apparent Volume of Distribution [Vd] | pharmacokinetic parameter | 24 hours postdose |
| Maximum Plasma Concentration [Cmax](after deduction of background) | pharmacokinetic parameter | 24 hours postdose |
| Area Under the Curve [AUC](after deduction of background) | pharmacokinetic parameter | 24 hours postdose |
| Tmax(after deduction of background) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital | Shanghai | Shanghai Municipality | 200040 | China |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ALA 10% | Drug | prepare 10% ALA solution, apply topically to the affected area for 3 hours, single dose |
|
pharmacokinetic parameter
| 24 hours postdose |
| Half-life Time [T1/2](after deduction of background) | pharmacokinetic parameter | 24 hours postdose |
| Clearance [CL](after deduction of background) | pharmacokinetic parameter | 24 hours postdose |
| Apparent Volume of Distribution [Vd](after deduction of background) | pharmacokinetic parameter | 24 hours postdose |
| Incidence of adverse events | Number of participants with treatment related adverse events as assessed by physical examination, vital signs, clinical laboratory values, local skin responses | 2 days postdose |