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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04018885
• Other study ID #: F0014-ALA-201809
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 11, 2019
• Est. completion date: January 20, 2020

Study information

• Verified date: June 2020
• Source: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 20, 2020
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
China	The General Hospital of the People's Liberation Army	Beijing
China	Hospital for Skin Diseases, Chinese Academy of Medical Sciences	Nanjing	Jiangsu
China	Huashan Hospital	Shanghai	Shanghai
China	Shanghai Dermatology Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Percent Changes From Baseline in Total Lesion Counts		8 weeks after the last treatment
Primary	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	Percent Change from Baseline in inflammatory and non-inflammatory lesion counts		4, 8 weeks after the last treatment
Secondary	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
Secondary	Proportion of acne severity improvement as assessed with the Investigator's Global Assessment (IGA)		4, 8 weeks after the last treatment
Secondary	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