A Study on Safety and Preliminary Efficacy of ALA in Acne Vulgaris

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-center, Open, Randomized, Parallel Group Study to Assess Safety, Tolerance and Preliminary Efficacy of ALA for the Treatment of Moderate to Severe Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: ALA 2.5%
* Drug: ALA 5%
* Drug: ALA 10%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chinese male or female patients aged 18 - 40 years; Grade III-IV facial acne vulgaris according to the Pillsbury International Improvement scale.; All patients claimed to take effective contraception from 14 days before to 1 month after the end of the study, (among those who had used contraceptive two weeks prior to the study, the dosage of the drug should remain the same throughout the study) and had no fertility or donation of sperm/egg plan; Informed consents were signed. Exclusion Criteria: Suffering with malignant tumors, cardiac, endocrine, blood, liver, immunity, metabolism, urinary system, lungs, nervous system, rheumatism / joint, psychology and kidney diseases; Obviously abnormal liver and kidney function; Suffering with allergy diseases; suspected or known to have porphyria; allergic to studying drugs and / or porphyrin; allergic to visible light; allergic constitution (allergic to two or more drugs, food or pollen); Secondary acne patients, such as occupational acne or acne caused by corticosteroids; Complicated with other obvious facial skin diseases such as actinic dermatitis, psoriasis, seborrheic dermatitis, eczema, skin tumors, etc; Other diseases that may significantly affect the efficacy evaluation; Pregnancy, lactation patients; Exposed to systemic retinoids 2 months prior to the study (acitretin for 6 months); Exposed to systemic antibiotics, glucocorticoids, spironolactone and other drugs for treating acne 4 weeks prior to the study; physical therapy for the treatment of acne; Exposed to topical retinoids on the face 4 weeks prior to the study or topical antibiotics, glucocorticoids, and other topical treatment 2 weeks prior to the study; Participated in other clinical trials 3 months prior to the study; Other reasons that the investigator considered inappropriate for participation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALA 2.5% 0.5h<br>Topical application of 2.5% ALA for 0.5 hour | Drug: ALA 2.5%<br>* 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.<br>|
| Experimental: ALA 2.5% 1.5h<br>Topical application of 2.5% ALA for 1.5 hours | Drug: ALA 2.5%<br>* 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.<br>|
| Experimental: ALA 2.5% 3h<br>Topical application of 2.5% ALA for 3 hours | Drug: ALA 2.5%<br>* 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.<br>|
| Experimental: ALA 5% 0.5h<br>Topical application of 5% ALA for 0.5 hour | Drug: ALA 5%<br>* 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.<br>|
| Experimental: ALA 5% 1.5h<br>Topical application of 5% ALA for 1.5 hours | Drug: ALA 5%<br>* 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.<br>|
| Experimental: ALA 5% 3h<br>Topical application of 5% ALA for 3 hours | Drug: ALA 5%<br>* 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.<br>|
| Experimental: ALA 10% 0.5h<br>Topical application of 10% ALA for 0.5 hour | Drug: ALA 10%<br>* 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.<br>|
| Experimental: ALA 10% 1.5h<br>Topical application of 10% ALA for 1.5 hours | Drug: ALA 10%<br>* 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.<br>|
| Experimental: ALA 10% 3h<br>Topical application of 10% ALA for 3 hours | Drug: ALA 10%<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |