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出境医 / 临床实验 / A Study on Safety and Preliminary Efficacy of ALA in Acne Vulgaris

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

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: ALA 2.5% Drug: ALA 5% Drug: ALA 10% Phase 1 Phase 2

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 11, 2019
Actual Primary Completion Date : January 20, 2020
Actual Study Completion Date : January 20, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: ALA 2.5% 0.5h
Topical application of 2.5% ALA for 0.5 hour
 Drug: ALA 2.5%
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.
Experimental: ALA 2.5% 1.5h
Topical application of 2.5% ALA for 1.5 hours
 Drug: ALA 2.5%
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.
Experimental: ALA 2.5% 3h
Topical application of 2.5% ALA for 3 hours
 Drug: ALA 2.5%
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.
Experimental: ALA 5% 0.5h
Topical application of 5% ALA for 0.5 hour
 Drug: ALA 5%
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.
Experimental: ALA 5% 1.5h
Topical application of 5% ALA for 1.5 hours
 Drug: ALA 5%
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.
Experimental: ALA 5% 3h
Topical application of 5% ALA for 3 hours
 Drug: ALA 5%
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.
Experimental: ALA 10% 0.5h
Topical application of 10% ALA for 0.5 hour
 Drug: ALA 10%
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.
Experimental: ALA 10% 1.5h
Topical application of 10% ALA for 1.5 hours
 Drug: ALA 10%
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.
Experimental: ALA 10% 3h
Topical application of 10% ALA for 3 hours
 Drug: ALA 10%
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.
Outcome Measures
Primary Outcome Measures :
  1. Success rate in Investigator's Global Assessment (IGA)(8wks) [ Time Frame: 8 weeks after the last treatment ]
    Proportion of subjects with an assessment of clear or almost clear with at least a 2-grade improvement in IGA

  2. Percent Changes From Baseline in Total Lesion Counts [ Time Frame: 8 weeks after the last treatment ]
  3. Number of Participants With Treatment Related Adverse Events [ Time Frame: up to 8 weeks after last treatment ]
    Number of participants with treatment related adverse events as assessed by physical examination, vital signs, clinical laboratory values, local skin responses


Secondary Outcome Measures :
  1. Percent Change from Baseline in inflammatory and non-inflammatory lesion counts [ Time Frame: 4, 8 weeks after the last treatment ]
  2. Success rate in Investigator's Global Assessment (IGA)(4wks) [ Time Frame: 4 weeks after the last treatment ]
    Proportion of subjects with an assessment of clear or almost clear with at least a 2-grade improvement in IGA

  3. Proportion of acne severity improvement as assessed with the Investigator's Global Assessment (IGA) [ Time Frame: 4, 8 weeks after the last treatment ]
  4. Change in Quality of Life of Subjects from Baseline [ Time Frame: 4, 8 weeks after the last treatment ]
    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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Chinese male or female patients aged 18 - 40 years;
  2. Grade III-IV facial acne vulgaris according to the Pillsbury International Improvement scale.;
  3. 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;
  4. Informed consents were signed.

Exclusion Criteria:

  1. Suffering with malignant tumors, cardiac, endocrine, blood, liver, immunity, metabolism, urinary system, lungs, nervous system, rheumatism / joint, psychology and kidney diseases;
  2. Obviously abnormal liver and kidney function;
  3. 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);
  4. Secondary acne patients, such as occupational acne or acne caused by corticosteroids;
  5. Complicated with other obvious facial skin diseases such as actinic dermatitis, psoriasis, seborrheic dermatitis, eczema, skin tumors, etc;
  6. Other diseases that may significantly affect the efficacy evaluation;
  7. Pregnancy, lactation patients;
  8. Exposed to systemic retinoids 2 months prior to the study (acitretin for 6 months);
  9. 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;
  10. 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;
  11. Participated in other clinical trials 3 months prior to the study;
  12. Other reasons that the investigator considered inappropriate for participation in the study.
Contacts and Locations

Locations
Layout table for location information
China, Jiangsu
Hospital for Skin Diseases, Chinese Academy of Medical Sciences
Nanjing, Jiangsu, China
China, Shanghai
Huashan Hospital
Shanghai, Shanghai, China, 200040
Shanghai Dermatology Hospital
Shanghai, Shanghai, China
China
The General Hospital of the People's Liberation Army
Beijing, China
Sponsors and Collaborators
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Tracking Information
First Submitted Date  ICMJE July 10, 2019
First Posted Date  ICMJE July 15, 2019
Last Update Posted Date June 2, 2020
Actual Study Start Date  ICMJE July 11, 2019
Actual Primary Completion Date January 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
  • Success rate in Investigator's Global Assessment (IGA)(8wks) [ Time Frame: 8 weeks after the last treatment ]
    Proportion of subjects with an assessment of clear or almost clear with at least a 2-grade improvement in IGA
  • Percent Changes From Baseline in Total Lesion Counts [ Time Frame: 8 weeks after the last treatment ]
  • Number of Participants With Treatment Related Adverse Events [ Time Frame: up to 8 weeks after last treatment ]
    Number of participants with treatment related adverse events as assessed by physical examination, vital signs, clinical laboratory values, local skin responses
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
  • Percent Change from Baseline in inflammatory and non-inflammatory lesion counts [ Time Frame: 4, 8 weeks after the last treatment ]
  • Success rate in Investigator's Global Assessment (IGA)(4wks) [ Time Frame: 4 weeks after the last treatment ]
    Proportion of subjects with an assessment of clear or almost clear with at least a 2-grade improvement in IGA
  • Proportion of acne severity improvement as assessed with the Investigator's Global Assessment (IGA) [ Time Frame: 4, 8 weeks after the last treatment ]
  • Change in Quality of Life of Subjects from Baseline [ Time Frame: 4, 8 weeks after the last treatment ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study on Safety and Preliminary Efficacy of ALA in Acne Vulgaris
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: ALA 2.5%
    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.
  • Drug: ALA 5%
    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.
  • Drug: ALA 10%
    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.
Study Arms  ICMJE
  • Experimental: ALA 2.5% 0.5h
    Topical application of 2.5% ALA for 0.5 hour
    Intervention: Drug: ALA 2.5%
  • Experimental: ALA 2.5% 1.5h
    Topical application of 2.5% ALA for 1.5 hours
    Intervention: Drug: ALA 2.5%
  • Experimental: ALA 2.5% 3h
    Topical application of 2.5% ALA for 3 hours
    Intervention: Drug: ALA 2.5%
  • Experimental: ALA 5% 0.5h
    Topical application of 5% ALA for 0.5 hour
    Intervention: Drug: ALA 5%
  • Experimental: ALA 5% 1.5h
    Topical application of 5% ALA for 1.5 hours
    Intervention: Drug: ALA 5%
  • Experimental: ALA 5% 3h
    Topical application of 5% ALA for 3 hours
    Intervention: Drug: ALA 5%
  • Experimental: ALA 10% 0.5h
    Topical application of 10% ALA for 0.5 hour
    Intervention: Drug: ALA 10%
  • Experimental: ALA 10% 1.5h
    Topical application of 10% ALA for 1.5 hours
    Intervention: Drug: ALA 10%
  • Experimental: ALA 10% 3h
    Topical application of 10% ALA for 3 hours
    Intervention: Drug: ALA 10%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2019) 		72
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 20, 2020
Actual Primary Completion Date January 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Chinese male or female patients aged 18 - 40 years;
  2. Grade III-IV facial acne vulgaris according to the Pillsbury International Improvement scale.;
  3. 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;
  4. Informed consents were signed.

Exclusion Criteria:

  1. Suffering with malignant tumors, cardiac, endocrine, blood, liver, immunity, metabolism, urinary system, lungs, nervous system, rheumatism / joint, psychology and kidney diseases;
  2. Obviously abnormal liver and kidney function;
  3. 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);
  4. Secondary acne patients, such as occupational acne or acne caused by corticosteroids;
  5. Complicated with other obvious facial skin diseases such as actinic dermatitis, psoriasis, seborrheic dermatitis, eczema, skin tumors, etc;
  6. Other diseases that may significantly affect the efficacy evaluation;
  7. Pregnancy, lactation patients;
  8. Exposed to systemic retinoids 2 months prior to the study (acitretin for 6 months);
  9. 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;
  10. 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;
  11. Participated in other clinical trials 3 months prior to the study;
  12. Other reasons that the investigator considered inappropriate for participation in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04018885
Other Study ID Numbers  ICMJE F0014-ALA-201809
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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