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

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ClinicalTrials.gov Identifier: NCT04018885
Recruitment Status : Recruiting
First Posted : July 15, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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.




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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018885


Contacts
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Contact: Leihong Xiang, MD +86-21-52887775 flora_xiang@vip.163.com
Contact: Xiuli Wang, MD +86-21-61833004 xlwang2001@aliyun.com

Locations
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China, Jiangsu
Hospital for Skin Diseases, Chinese Academy of Medical Sciences Recruiting
Nanjing, Jiangsu, China
China, Shanghai
Huashan Hospital Recruiting
Shanghai, Shanghai, China, 200040
Contact: Cuiyun Wu, BA    +86-21-52888045    wucuiyun@fudan.edu.cn   
Shanghai Dermatology Hospital Recruiting
Shanghai, Shanghai, China
China
The General Hospital of the People's Liberation Army Not yet recruiting
Beijing, China
Sponsors and Collaborators
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

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Responsible Party: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT04018885     History of Changes
Other Study ID Numbers: F0014-ALA-201809
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases