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

Acne Vulgaris Clinical Trial

Official title:

Adverse Effects of ALA-PDT for the Treatment of Moderate to Severe Acne

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04709289
• Other study ID #: 2020-04
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: February 28, 2020

Study information

• Verified date: January 2021
• Source: Shanghai Dermatology Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 28, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Other:
• Aminolevulinic acid, photodynamic therapy
Aminolevulinic acid, photodynamic therapy

Locations

Country	Name	City	State
China	Lei Shi	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Dermatology Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The clearance rate of lesions	The change rate in lesion clearance of acne vulgaris at 7 days after treatment will be measured as the primary outcome	1 week after treatment
Secondary	Assessment of adverse effects	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.	up to 7 days after treatment.