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

NCT ID: NCT04018885

Last Updated: 2020-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-11
• Study Completion Date: 2020-01-20

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ALA 2.5% 0.5h

Topical application of 2.5% ALA for 0.5 hour

Group Type: EXPERIMENTAL

ALA 2.5%

Intervention Type: DRUG

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 2.5% 1.5h

Topical application of 2.5% ALA for 1.5 hours

Group Type: EXPERIMENTAL

ALA 2.5%

Intervention Type: DRUG

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 2.5% 3h

Topical application of 2.5% ALA for 3 hours

Group Type: EXPERIMENTAL

ALA 2.5%

Intervention Type: DRUG

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% 0.5h

Topical application of 5% ALA for 0.5 hour

Group Type: EXPERIMENTAL

ALA 5%

Intervention Type: DRUG

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% 1.5h

Topical application of 5% ALA for 1.5 hours

Group Type: EXPERIMENTAL

ALA 5%

Intervention Type: DRUG

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% 3h

Topical application of 5% ALA for 3 hours

Group Type: EXPERIMENTAL

ALA 5%

Intervention Type: DRUG

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% 0.5h

Topical application of 10% ALA for 0.5 hour

Group Type: EXPERIMENTAL

ALA 10%

Intervention Type: DRUG

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% 1.5h

Topical application of 10% ALA for 1.5 hours

Group Type: EXPERIMENTAL

ALA 10%

Intervention Type: DRUG

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% 3h

Topical application of 10% ALA for 3 hours

Group Type: EXPERIMENTAL

ALA 10%

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital for Skin Diseases, Chinese Academy of Medical Sciences

Nanjing, Jiangsu, China

Huashan Hospital

Shanghai, Shanghai Municipality, China

Shanghai Dermatology Hospital

Shanghai, Shanghai Municipality, China

The General Hospital of the People's Liberation Army

Beijing, , China

Countries

China

Other Identifiers

F0014-ALA-201809

Identifier Type: -

Identifier Source: org_study_id