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

NCT04018885 | Completed Phase 1

• 1 other identifier: F0014-ALA-201809
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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)

  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

  4, 8 weeks after the last treatment

Study Arms (9)

ALA 2.5% 0.5h

EXPERIMENTAL

Topical application of 2.5% ALA for 0.5 hour

Drug: ALA 2.5%

ALA 2.5% 1.5h

EXPERIMENTAL

Topical application of 2.5% ALA for 1.5 hours

Drug: ALA 2.5%

ALA 2.5% 3h

EXPERIMENTAL

Topical application of 2.5% ALA for 3 hours

Drug: ALA 2.5%

ALA 5% 0.5h

EXPERIMENTAL

Topical application of 5% ALA for 0.5 hour

Drug: ALA 5%

ALA 5% 1.5h

EXPERIMENTAL

Topical application of 5% ALA for 1.5 hours

Drug: ALA 5%

ALA 5% 3h

EXPERIMENTAL

Topical application of 5% ALA for 3 hours

Drug: ALA 5%

ALA 10% 0.5h

EXPERIMENTAL

Topical application of 10% ALA for 0.5 hour

Drug: ALA 10%

ALA 10% 1.5h

EXPERIMENTAL

Topical application of 10% ALA for 1.5 hours

Drug: ALA 10%

ALA 10% 3h

EXPERIMENTAL

Topical application of 10% ALA for 3 hours

Drug: ALA 10%

Interventions

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 2.5% 0.5h; ALA 2.5% 1.5h; ALA 2.5% 3h

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 5% 0.5h; ALA 5% 1.5h; ALA 5% 3h

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.

ALA 10% 0.5h; ALA 10% 1.5h; ALA 10% 3h

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (4)

Hospital for Skin Diseases, Chinese Academy of Medical Sciences

Nanjing, Jiangsu, China

Location

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

Shanghai Dermatology Hospital

Shanghai, Shanghai Municipality, China

Location

The General Hospital of the People's Liberation Army

Beijing, China

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 15, 2019
• Study Start: July 11, 2019
• Primary Completion: January 20, 2020
• Study Completion: January 20, 2020
• Last Updated: June 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)