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The purpose of this study is to explore the safety, tolerability, and preliminary efficacy of ALA used with photodynamic therapy for the treatment of moderate to severe acne vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALA 2.5% 0.5h | Experimental | Topical application of 2.5% ALA for 0.5 hour |
|
| ALA 2.5% 1.5h | Experimental | Topical application of 2.5% ALA for 1.5 hours |
|
| ALA 2.5% 3h | Experimental | Topical application of 2.5% ALA for 3 hours |
|
| ALA 5% 0.5h | Experimental | Topical application of 5% ALA for 0.5 hour |
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| ALA 5% 1.5h | Experimental | Topical application of 5% ALA for 1.5 hours |
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| ALA 5% 3h | Experimental | Topical application of 5% ALA for 3 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALA 2.5% | Drug | Topical treatment for photodynamic therapy, after drug incubation subsequent illumination with red light (72 J/cm2). 4 treatments at an interval of 10 (± 4) days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success rate in Investigator's Global Assessment (IGA)(8wks) | Proportion of subjects with an assessment of clear or almost clear with at least a 2-grade improvement in IGA | 8 weeks after the last treatment |
| Percent Changes From Baseline in Total Lesion Counts | 8 weeks after the last treatment | |
| Number of Participants With Treatment Related Adverse Events | Number of participants with treatment related adverse events as assessed by physical examination, vital signs, clinical laboratory values, local skin responses | up to 8 weeks after last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in inflammatory and non-inflammatory lesion counts | 4, 8 weeks after the last treatment | |
| Success rate in Investigator's Global Assessment (IGA)(4wks) | Proportion of subjects with an assessment of clear or almost clear with at least a 2-grade improvement in IGA |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Skin Diseases, Chinese Academy of Medical Sciences | Nanjing | Jiangsu | China | |||
| Huashan Hospital |
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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% 0.5h |
| Experimental |
Topical application of 10% ALA for 0.5 hour |
|
| ALA 10% 1.5h | Experimental | Topical application of 10% ALA for 1.5 hours |
|
| ALA 10% 3h | Experimental | Topical application of 10% ALA for 3 hours |
|
| ALA 5% | Drug | Topical treatment for photodynamic therapy, after drug incubation subsequent illumination with red light (72 J/cm2). 4 treatments at an interval of 10 (± 4) days. |
|
| ALA 10% | Drug | Topical treatment for photodynamic therapy, after drug incubation subsequent illumination with red light (72 J/cm2). 4 treatments at an interval of 10 (± 4) days. |
|
| 4 weeks after the last treatment |
| Proportion of acne severity improvement as assessed with the Investigator's Global Assessment (IGA) | 4, 8 weeks after the last treatment |
| Change in Quality of Life of Subjects from Baseline | Change in Quality of life will be assessed based on Acne-specific Quality of Life Questionnaire to be filled by subjects before and 4/8 weeks after last treatment | 4, 8 weeks after the last treatment |
| Shanghai |
| Shanghai Municipality |
| 200040 |
| China |
| Shanghai Dermatology Hospital | Shanghai | Shanghai Municipality | China |
| The General Hospital of the People's Liberation Army | Beijing | China |