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

Last updated: November 23, 2020
Sponsor: Shanghai Dermatology Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rash

Acne

Inflammatory Comedones

Treatment

N/A

Clinical Study ID

NCT04167982
2019-11
  • Ages 18-40
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 programrequirements
  • 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 informedconsent when they had informed other alternatives and agreed to take pictures of thelesion

Exclusion

Exclusion Criteria:

  • Those who did not complete the informed consent
  • The lesions belongs to any of the following conditions: There is damage andinflammation, 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 chemicallysimilar 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 andimmunosuppressants
  • 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 -Thosewith a history of drug abuse; those who have participated in other drug clinicaltrials within 4 weeks before treatment

Study Design

Total Participants: 234
Study Start date:
March 28, 2020
Estimated Completion Date:
November 30, 2022

Connect with a study center

  • Lei Shi

    Shanghai, Shanghai 200443
    China

    Active - Recruiting

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