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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ALA 2.5%
ALA 5%
ALA 10%
Sponsored by
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

ALA 2.5% 0.5h

ALA 2.5% 1.5h

ALA 2.5% 3h

ALA 5% 0.5h

ALA 5% 1.5h

ALA 5% 3h

ALA 10% 0.5h

ALA 10% 1.5h

ALA 10% 3h

Arm Description

Topical application of 2.5% ALA for 0.5 hour

Topical application of 2.5% ALA for 1.5 hours

Topical application of 2.5% ALA for 3 hours

Topical application of 5% ALA for 0.5 hour

Topical application of 5% ALA for 1.5 hours

Topical application of 5% ALA for 3 hours

Topical application of 10% ALA for 0.5 hour

Topical application of 10% ALA for 1.5 hours

Topical application of 10% ALA for 3 hours

Outcomes

Primary Outcome Measures

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
Percent Changes From Baseline in Total Lesion Counts
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

Secondary Outcome Measures

Percent Change from Baseline in inflammatory and non-inflammatory lesion counts
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
Proportion of acne severity improvement as assessed with the Investigator's Global Assessment (IGA)
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

Full Information

First Posted
July 10, 2019
Last Updated
June 1, 2020
Sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04018885
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 11, 2019 (Actual)
Primary Completion Date
January 20, 2020 (Actual)
Study Completion Date
January 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALA 2.5% 0.5h
Arm Type
Experimental
Arm Description
Topical application of 2.5% ALA for 0.5 hour
Arm Title
ALA 2.5% 1.5h
Arm Type
Experimental
Arm Description
Topical application of 2.5% ALA for 1.5 hours
Arm Title
ALA 2.5% 3h
Arm Type
Experimental
Arm Description
Topical application of 2.5% ALA for 3 hours
Arm Title
ALA 5% 0.5h
Arm Type
Experimental
Arm Description
Topical application of 5% ALA for 0.5 hour
Arm Title
ALA 5% 1.5h
Arm Type
Experimental
Arm Description
Topical application of 5% ALA for 1.5 hours
Arm Title
ALA 5% 3h
Arm Type
Experimental
Arm Description
Topical application of 5% ALA for 3 hours
Arm Title
ALA 10% 0.5h
Arm Type
Experimental
Arm Description
Topical application of 10% ALA for 0.5 hour
Arm Title
ALA 10% 1.5h
Arm Type
Experimental
Arm Description
Topical application of 10% ALA for 1.5 hours
Arm Title
ALA 10% 3h
Arm Type
Experimental
Arm Description
Topical application of 10% ALA for 3 hours
Intervention Type
Drug
Intervention Name(s)
ALA 2.5%
Intervention Description
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
Intervention Name(s)
ALA 5%
Intervention Description
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
Intervention Name(s)
ALA 10%
Intervention Description
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 Measure Information:
Title
Success rate in Investigator's Global Assessment (IGA)(8wks)
Description
Proportion of subjects with an assessment of clear or almost clear with at least a 2-grade improvement in IGA
Time Frame
8 weeks after the last treatment
Title
Percent Changes From Baseline in Total Lesion Counts
Time Frame
8 weeks after the last treatment
Title
Number of Participants With Treatment Related Adverse Events
Description
Number of participants with treatment related adverse events as assessed by physical examination, vital signs, clinical laboratory values, local skin responses
Time Frame
up to 8 weeks after last treatment
Secondary Outcome Measure Information:
Title
Percent Change from Baseline in inflammatory and non-inflammatory lesion counts
Time Frame
4, 8 weeks after the last treatment
Title
Success rate in Investigator's Global Assessment (IGA)(4wks)
Description
Proportion of subjects with an assessment of clear or almost clear with at least a 2-grade improvement in IGA
Time Frame
4 weeks after the last treatment
Title
Proportion of acne severity improvement as assessed with the Investigator's Global Assessment (IGA)
Time Frame
4, 8 weeks after the last treatment
Title
Change in Quality of Life of Subjects from Baseline
Description
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
Time Frame
4, 8 weeks after the last treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chinese male or female patients aged 18 - 40 years; Grade III-IV facial acne vulgaris according to the Pillsbury International Improvement scale.; 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; Informed consents were signed. Exclusion Criteria: Suffering with malignant tumors, cardiac, endocrine, blood, liver, immunity, metabolism, urinary system, lungs, nervous system, rheumatism / joint, psychology and kidney diseases; Obviously abnormal liver and kidney function; 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); Secondary acne patients, such as occupational acne or acne caused by corticosteroids; Complicated with other obvious facial skin diseases such as actinic dermatitis, psoriasis, seborrheic dermatitis, eczema, skin tumors, etc; Other diseases that may significantly affect the efficacy evaluation; Pregnancy, lactation patients; Exposed to systemic retinoids 2 months prior to the study (acitretin for 6 months); 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; 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; Participated in other clinical trials 3 months prior to the study; Other reasons that the investigator considered inappropriate for participation in the study.
Facility Information:
Facility Name
Hospital for Skin Diseases, Chinese Academy of Medical Sciences
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Huashan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai Dermatology Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
The General Hospital of the People's Liberation Army
City
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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