Efficacy and Safety of Painless 5-aminolevulinic Acid Photodynamic Therapy for Moderate and Severe Acne Vulgaris

  • End date
    Nov 30, 2022
  • participants needed
  • sponsor
    Shanghai Dermatology Hospital
Updated on 18 February 2022
aminolevulinic acid
photodynamic therapy


This study is being done to compare a new, continuous illumination and short Incubation time regimen of 5-aminolevulinic acid photodynamic therapy (painless ALA- PDT) to low-dose and conventional dose of oral isotretinoin for treatment of moderate or severe acne vulgaris. The hypothesis is that the painless ALA- PDT will be equally or more efficacious as oral isotretinoin, and taking effect more quickly with less adverse effect.

Condition Acne
Treatment Aminolevulinic acid photodynamic therapy, Oral conventional-dose isotretinoin, Oral low-dose isotretinoin
Clinical Study IdentifierNCT04167982
SponsorShanghai Dermatology Hospital
Last Modified on18 February 2022


Yes No Not Sure

Inclusion Criteria

Clinical diagnosed with moderate to severe acne
Male and female patients of age between 18-40 years old
All patients read the instructions of the subject, willing to follow the program requirements
No other topical treatment received within 2 weeks prior to enrollment
No systemic treatment was given within 4 weeks prior to enrollment
Patients were unsuitable for other treatments for various reasons and signed informed consent when they had informed other alternatives and agreed to take pictures of the lesion

Exclusion Criteria

Those who did not complete the informed consent
The lesions belongs to any of the following conditions: There is damage and inflammation, which may lead to the drug entering the open wound
Patients with skin photoallergic diseases, porphyria
Known to have a history of allergies to test drugs (porphyrins) and their chemically similar drugs
Patients with other obvious diseases that may affect the evaluation of efficacy
Scars or patients with a tendency to form scars
Known to have severe immune dysfunction, or long-term use of glucocorticoids and immunosuppressants
Severe heart, liver, kidney disease; with hereditary or acquired coagulopathy
Those with severe neurological, psychiatric or endocrine diseases
Women who are pregnant, breast-feeding or using inappropriate contraceptives -Those with a history of drug abuse; those who have participated in other drug clinical trials within 4 weeks before treatment
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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