Adverse Effects of ALA-PDT for the Treatment of Moderate to Severe Acne Vulgaris: a Prospective Study

Shanghai Dermatology Hospital

Status: Completed

Conditions: Acne Vulgaris

Treatments: Other: Aminolevulinic acid, photodynamic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04709289

2020-04

Details and patient eligibility

About

To understand, prevent and treat the adverse reactions more comprehensively, we sought to systemically document the adverse effects of ALA-PDT for moderate to severe acne vulgaris.

Full description

To understand, prevent and treat the adverse reactions more comprehensively, we sought to systemically document the adverse effects of ALA-PDT for moderate to severe acne vulgaris.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (1) Patients diagnosed with moderate to severe acne and graded grade III-IV according to Investigator's Global Assessment (IGA) ;
• (2) Patients unsuitable for drug treatment owing to various reasons and who voluntarily participated and signed informed consent following information about other alternatives;
• (3) Patients who read the instructions and were willing to follow the program requirements.

Exclusion criteria

• (1) Patients who had a history of photosensitive diseases;
• (2) Patients who had Modified-PDT;
• (3) Patients who had oral isotretinoin in the past 3 months, used oral contraceptives or antibiotics and underwent local or facial surgery in the past 4 weeks;
• (4) Female patients who were pregnant or lactating.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Conventional Photodynamic Therapy(C-PDT) group

Experimental group

Description:

The conventional photodynamic therapy(C-PDT) group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 140 J/cm2) after applying 5% 5-aminolevulinic acid cream for 3h.A repeat treatment was administered once every two weeks for 3 times.

Treatment:

Other: Aminolevulinic acid, photodynamic therapy