Clinical trial NCT04018885: A Study on Safety and Preliminary Efficacy of ALA in Acne Vulgaris
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-07-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Success rate in Investigator's Global Assessment (IGA)(8wks)
timeFrame: 8 weeks after the last treatment
measure: Percent Changes From Baseline in Total Lesion Counts
timeFrame: 8 weeks after the last treatment
measure: Number of Participants With Treatment Related Adverse Events
timeFrame: up to 8 weeks after last treatment
Secondary outcomes:
measure: Percent Change from Baseline in inflammatory and non-inflammatory lesion counts
timeFrame: 4, 8 weeks after the last treatment
measure: Success rate in Investigator's Global Assessment (IGA)(4wks)
timeFrame: 4 weeks after the last treatment
measure: Proportion of acne severity improvement as assessed with the Investigator's Global Assessment (IGA)
timeFrame: 4, 8 weeks after the last treatment
measure: Change in Quality of Life of Subjects from Baseline
timeFrame: 4, 8 weeks after the last treatment
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Hospital for Skin Diseases, Chinese Academy of Medical Sciences
state: Jiangsu
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Dermatology Hospital
state: Shanghai
city: Beijing
country: China
facility: The General Hospital of the People's Liberation Army
Study officials:
References: