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

Not Applicable

Completed

• Conditions: Acne Vulgaris
• Interventions: Other: Aminolevulinic acid, photodynamic therapy

• Registration Number: NCT04709289
• Lead Sponsor: Shanghai Dermatology Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-02-28
• Status Verified: 2021-01
• Study First Submitted: 2021-01-10
• Study First Submitted QC: 2021-01-13
• Last Update Submitted: 2021-01-13
• Study First Posted: 2021-01-14
• Last Update Posted: 2021-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Conventional Photodynamic Therapy(C-PDT) group	Aminolevulinic acid, photodynamic therapy	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.

Primary Outcome Measures

Name	Time	Method
The clearance rate of lesions	1 week after treatment	The change rate in lesion clearance of acne vulgaris at 7 days after treatment will be measured as the primary outcome

Secondary Outcome Measures

Name	Time	Method
Assessment of adverse effects	up to 7 days after treatment.	the incidence, severity, occurrence and duration time of erythema, pain, burning skin, itching, pustule, exudation, edema, blister, dry skin, crust and hyperpigmentation of last treatment, as well as lesion photos were detailed asked and recorded during the clinical encounter, up to 7 days after treatment.

Trial Locations

Locations (1)

Lei Shi; 🇨🇳 Shanghai, Shanghai, China