Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Moderate or Severe Acne

NCT ID: NCT03961607

Last Updated: 2019-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-10
• Study Completion Date: 2019-12-30

Brief Summary

This study is being done to compare a new, continuous illumination and short Incubation time regimen of aminolevulinic acid photodynamic therapy#ALA- PDT) to a conventional regimen for treatment of Moderate or Severe Acne. The hypothesis is that the continuous illumination approach will be less or even no painful, but equally efficacious, as the old regimen.

Conditions

Acne

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Painless Photodynamic Therapy(P-PDT) group

The painless photodynamic therapy group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 150 J/cm2) after applying 5% 5-aminolevulinic acid#ALA#cream for 30min. A repeat treatment was administered once weekly for a maximum of 3 weeks.

Group Type: EXPERIMENTAL

Aminolevulinic acid photodynamic therapy

Intervention Type: PROCEDURE

Aminolevulinic acid photodynamic therapy

Conventional Photodynamic Therapy(C-PDT) group

The conventional photodynamic therapy(C-PDT) group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 50 J/cm2) after applying 5% 5-aminolevulinic acid cream for 1.5h.A repeat treatment was administered once weekly for a maximum of 3 weeks.

Group Type: ACTIVE_COMPARATOR

Aminolevulinic acid photodynamic therapy

Intervention Type: PROCEDURE

Aminolevulinic acid photodynamic therapy

Interventions

Aminolevulinic acid photodynamic therapy

Aminolevulinic acid photodynamic therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Clinical diagnosed with moderate to severe acne;

2. Male and female patients of age between 18-30 years old ;

3. All patients read the instructions of the subject, willing to follow the program requirements;

4. No other topical treatment received within 2 weeks prior to enrollment;

5. No systemic treatment was given within 4 weeks prior to enrollment;

6. Patients were unsuitable for surgery for various reasons,unwilling to undergo surgery, and signed informed consent when they had informed other alternatives and agreed to take pictures of the lesion. -

Exclusion Criteria

1. Those who did not complete the informed consent;

2. The lesions belongs to any of the following conditions: There is damage and inflammation, which may lead to the drug entering the open wound;

3. Patients with skin photoallergic diseases, porphyria;

4. Known to have a history of allergies to test drugs (porphyrins) and their chemically similar drugs;

5. Patients with other obvious diseases that may affect the evaluation of efficacy;

6. Scars or patients with a tendency to form scars;

7. Known to have severe immune dysfunction, or long-term use of glucocorticoids and immunosuppressants;

8. Severe heart, liver, kidney disease; with hereditary or acquired People with sexual coagulopathy;

9. Those with severe neurological, psychiatric or endocrine diseases; (10)Women who are pregnant, breast-feeding or using inappropriate contraceptives; those with a history of drug abuse; those who have participated in other drug clinical trials within 4 weeks before treatment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Dermatology Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiuli Wang

Director, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiuli Wang, PhD, MD

Role: STUDY_CHAIR

Shanghai Skin Disease Hospital

Locations

Yunfeng Zhang

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yunfeng Zhang, MD

Role: CONTACT

yunfeng0519116@aliyun.com

+86-18017336550

Haiyan Zhang, MD

Role: CONTACT

zhanghaiyan10842@163.com

+86-18017336573

Facility Contacts

Yunfeng Zhang, MD

Role: primary

yunfeng0519116@aliyun.com

Haiyan Zhang, MD

Role: backup

zhanghaiyan10842@163.com

Other Identifiers

2019-10

Identifier Type: -

Identifier Source: org_study_id