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Completed

NCT Number: NCT04018885

A Study on Safety and Preliminary Efficacy of ALA in 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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital for Skin Diseases, Chinese Academy of Medical Sciences, Nanjing, Jiangsu, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ALA 2.5%

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%

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%

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.

Primary outcomes

  1. Success rate in Investigator's Global Assessment (IGA)(8wks)

    Time frame: 8 weeks after the last treatment

    Proportion of subjects with an assessment of clear or almost clear with at least a 2-grade improvement in IGA

  2. Percent Changes From Baseline in Total Lesion Counts

    Time frame: 8 weeks after the last treatment

  3. Number of Participants With Treatment Related Adverse Events

    Time frame: up to 8 weeks after last treatment

    Number of participants with treatment related adverse events as assessed by physical examination, vital signs, clinical laboratory values, local skin responses

Secondary outcomes

  1. Percent Change from Baseline in inflammatory and non-inflammatory lesion counts

    Time frame: 4, 8 weeks after the last treatment

  2. Success rate in Investigator's Global Assessment (IGA)(4wks)

    Time frame: 4 weeks after the last treatment

    Proportion of subjects with an assessment of clear or almost clear with at least a 2-grade improvement in IGA

  3. Proportion of acne severity improvement as assessed with the Investigator's Global Assessment (IGA)

    Time frame: 4, 8 weeks after the last treatment

  4. Change in Quality of Life of Subjects from Baseline

    Time frame: 4, 8 weeks after the last treatment

    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

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 15, 2019
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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