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

November 23, 2020 updated by: Shanghai Dermatology Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

234

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200443
        • Recruiting
        • Lei Shi
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Painless Photodynamic Therapy(P-PDT) group
The painless photodynamic therapy group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 150 J/cm2) after applying 5% 5-aminolevulinic acid(ALA) cream for 30min. A repeat treatment was administered once weekly for a maximum of 5 times. Blood samples, urine routine, blood biochemistry and electrocardiogram were performed before treatment and after treatment.
Procedure: Aminolevulinic acid photodynamic therapy
Aminolevulinic acid photodynamic therapy
Active Comparator: conventional-dose isotretinoin group
Patients in the conventional-dose isotretinoin group were given oral isotretinoin 0.5 mg/kg daily for 6 months, and the cumulative dose was 90 mg/kg. Time for subsequent visit: once every two weeks during the 1st and 2nd months, monthly during 3rd to 6th months. Blood samples, urine routine, blood biochemistry and electrocardiogram were performed before treatment and 2nd , 6th months after treatment.
Drug: Oral conventional-dose isotretinoin
Conventional-dose isotretinoin
Active Comparator: low-dose isotretinoin group
Patients in the low-dose isotretinoin group were given oral isotretinoin 0.2 mg/kg daily for 6 months, and the cumulative dose was 36 mg/kg. Time for subsequent visit: once every two weeks during the 1st and 2nd months, monthly during 3rd to 6th months. Blood samples, urine routine, blood biochemistry and electrocardiogram were performed before treatment and 2nd , 6th months after treatment.
Drug: Oral low-dose isotretinoin
low-dose isotretinoin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The clearance rate of Moderate or Severe Acne
Time Frame: 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
The clearance rate of Moderate or Severe Acne will be measured at 1st month after the last treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain assessment
Time Frame: immediately, 1st minute, 3rd minute, 5th minute, 7th minute, 10th minute and 2nd hour, 12th hour, 24th hour and 48th hour after treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Dermatology Hospital

Collaborators

RenJi Hospital
Huadong Hospital

Investigators

  • Study Chair: Xiuli Wang, MD PhD, Shanghai Skin Disease Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2020

Primary Completion (Anticipated)

November 30, 2022

Study Completion (Anticipated)

November 30, 2022

Study Registration Dates

First Submitted

October 26, 2019

First Submitted That Met QC Criteria

November 15, 2019

First Posted (Actual)

November 19, 2019

Study Record Updates

Last Update Posted (Actual)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 23, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-11 (APHM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

One year after finishing this study and for permanency

IPD Sharing Access Criteria

anyone who search pubmed

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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