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Completed

NCT Number: NCT04709289

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

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lei Shi

Shanghai, Shanghai Municipality, 200443, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aminolevulinic acid, photodynamic therapy

Other

Aminolevulinic acid, photodynamic therapy

Primary outcomes

  1. The clearance rate of lesions

    Time frame: 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 outcomes

  1. Assessment of adverse effects

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shanghai Dermatology Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 14, 2021
Registry last updated
Jan 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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