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

Primary Purpose

Acne

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Aminolevulinic acid photodynamic therapy
Oral conventional-dose isotretinoin
Oral low-dose isotretinoin
Sponsored by
Shanghai Dermatology Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne focused on measuring Acne, low-dose isotretinoin, Photodynamic Therapy, Painless

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lei ShiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Painless Photodynamic Therapy(P-PDT) group

conventional-dose isotretinoin group

low-dose isotretinoin group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
October 26, 2019
Last Updated
November 23, 2020
Sponsor
Shanghai Dermatology Hospital
Collaborators
Huadong Hospital, RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04167982
Brief Title
Efficacy and Safety of Painless 5-aminolevulinic Acid Photodynamic Therapy for Moderate and Severe Acne Vulgaris
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 28, 2020 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Dermatology Hospital
Collaborators
Huadong Hospital, RenJi Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
Keywords
Acne, low-dose isotretinoin, Photodynamic Therapy, Painless

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
234 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Painless Photodynamic Therapy(P-PDT) group
Arm Type
Experimental
Arm Description
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.
Arm Title
conventional-dose isotretinoin group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
low-dose isotretinoin group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Aminolevulinic acid photodynamic therapy
Intervention Description
Aminolevulinic acid photodynamic therapy
Intervention Type
Drug
Intervention Name(s)
Oral conventional-dose isotretinoin
Intervention Description
Conventional-dose isotretinoin
Intervention Type
Drug
Intervention Name(s)
Oral low-dose isotretinoin
Intervention Description
low-dose isotretinoin
Primary Outcome Measure Information:
Title
The clearance rate of Moderate or Severe Acne
Description
The clearance rate of Moderate or Severe Acne will be measured at 1st month after the last treatment
Time Frame
The clearance rate of Moderate or Severe Acne will be measured at 1st month after the last treatment
Secondary Outcome Measure Information:
Title
Pain assessment
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Shi, MD PhD
Phone
18017336512
Email
leishinsh@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Linglin Zhang, MD
Phone
180173336872
Email
zhangll363@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiuli Wang, MD PhD
Organizational Affiliation
Shanghai Skin Disease Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Lei Shi
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200443
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Shi, MD PhD
Phone
18017336512
Email
leishinsh@163.com
First Name & Middle Initial & Last Name & Degree
linglin Zhang, MD
Phone
180173336872
Email
zhangll363@126.com
First Name & Middle Initial & Last Name & Degree
Xiuli Wang, PhD, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
One year after finishing this study and for permanency
IPD Sharing Access Criteria
anyone who search pubmed

Learn more about this trial

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

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