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

Acne Clinical Trial

Official title:

Efficacy and Safety of Painless 5-aminolevulinic Acid Photodynamic Therapy for the Treatment of Moderate and Severe Acne Vulgaris-- A Multi-center, Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04167982
• Other study ID #: 2019-11
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: November 2020
• Source: Shanghai Dermatology Hospital
• Contact: Lei Shi, MD PhD
• Phone: 18017336512
• Email: leishinsh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 234
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Procedure:
• Aminolevulinic acid photodynamic therapy
Aminolevulinic acid photodynamic therapy

Drug:
• Oral conventional-dose isotretinoin
Conventional-dose isotretinoin
• Oral low-dose isotretinoin
low-dose isotretinoin

Locations

Country	Name	City	State
China	Lei Shi	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Dermatology Hospital	Huadong Hospital, RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The clearance rate of Moderate or Severe Acne	The clearance rate of Moderate or Severe Acne will be measured at 1st month after the last treatment	The clearance rate of Moderate or Severe Acne will be measured at 1st month after the last treatment
Secondary	Pain assessment	The pain will be assessed using Visual Analogue Scale (NRS) with a score range of 0-10. The higher the score, the greater the pain, with 0 being no pain and 10 being the most unbearable pain. Pain will be measured at different time points during and after every treatment (including immediately, 1st minute, 3rd minute, 5th minute, 7th minute, 10th minute and 2nd hour, 12th hour, 24th hour and 48th hour after treatment.	immediately, 1st minute, 3rd minute, 5th minute, 7th minute, 10th minute and 2nd hour, 12th hour, 24th hour and 48th hour after treatment