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CompletedNCT04709289Updated Jan 14, 2021

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

An interventional study of Aminolevulinic acid, photodynamic therapy in Acne Vulgaris, sponsored by Shanghai Dermatology Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-14.

Sponsored by Shanghai Dermatology Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jan 2020, registered Jan 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acne Vulgaris

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03

In context

Acne Vulgaris

730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.

This study's enrollment of 40 is below the median of 69 across 628 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Shanghai Dermatology Hospital is the lead sponsor of 9 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Conventional Photodynamic Therapy(C-PDT) group

    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.

    Other: Aminolevulinic acid, photodynamic therapy

Interventions

  • OtherAminolevulinic acid, photodynamic therapy

    Aminolevulinic acid, photodynamic therapy

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 week after treatment

Secondary outcomes

  1. 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.

    Time frame: up to 7 days after treatment.

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Study locations

1 site
  • Lei Shi
    Shanghai, Shanghai 200443, China
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References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04709289
Lead sponsor
Shanghai Dermatology Hospital
Responsible party
Xiuli Wang (Director, Clinical Professor, Shanghai Dermatology Hospital) — Principal investigator
First posted
Jan 14, 2021
Start date
Jan 1, 2020
Primary completion
Jan 1, 2020
Completion
Feb 28, 2020
Last update
Jan 14, 2021

Study contacts

Xiuli Wang, MD PhD
study director · Shanghai Skin Disease Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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