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

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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: ALA 2.5%; Drug: ALA 5%; Drug: ALA 10%

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • The General Hospital of the People's Liberation Army
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Hospital for Skin Diseases, Chinese Academy of Medical Sciences
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Huashan Hospital
    • Shanghai, Shanghai, China
      • Shanghai Dermatology Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

9

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Percent Changes From Baseline in Total Lesion Counts		8 weeks after the last treatment
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change from Baseline in inflammatory and non-inflammatory lesion counts		4, 8 weeks after the last treatment
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
Proportion of acne severity improvement as assessed with the Investigator's Global Assessment (IGA)		4, 8 weeks after the last treatment
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

Collaborators and Investigators

• Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2019
• Primary Completion (Actual): January 20, 2020
• Study Completion (Actual): January 20, 2020

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 12, 2019
• First Posted (Actual): July 15, 2019

Study Record Updates

• Last Update Posted (Actual): June 2, 2020
• Last Update Submitted That Met QC Criteria: June 1, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: F0014-ALA-201809

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No