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Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Moderate or Severe Acne

Primary Purpose

Acne

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Aminolevulinic acid photodynamic therapy
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 Photodynamic Therapy, Conventional, Painless, Acne

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Clinical diagnosed with moderate to severe acne;
  2. Male and female patients of age between 18-30 years old ;
  3. All patients read the instructions of the subject, willing to follow the program requirements;
  4. No other topical treatment received within 2 weeks prior to enrollment;
  5. No systemic treatment was given within 4 weeks prior to enrollment;
  6. Patients were unsuitable for surgery for various reasons,unwilling to undergo surgery, and signed informed consent when they had informed other alternatives and agreed to take pictures of the lesion. -

Exclusion Criteria:

  1. Those who did not complete the informed consent;
  2. The lesions belongs to any of the following conditions: There is damage and inflammation, which may lead to the drug entering the open wound;
  3. Patients with skin photoallergic diseases, porphyria;
  4. Known to have a history of allergies to test drugs (porphyrins) and their chemically similar drugs;
  5. Patients with other obvious diseases that may affect the evaluation of efficacy;
  6. Scars or patients with a tendency to form scars;
  7. Known to have severe immune dysfunction, or long-term use of glucocorticoids and immunosuppressants;
  8. Severe heart, liver, kidney disease; with hereditary or acquired People with sexual coagulopathy;
  9. Those with severe neurological, psychiatric or endocrine diseases; (10)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

  • Yunfeng ZhangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Painless Photodynamic Therapy(P-PDT) group

Conventional Photodynamic Therapy(C-PDT) 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 3 weeks.

The conventional photodynamic therapy(C-PDT) group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 50 J/cm2) after applying 5% 5-aminolevulinic acid cream for 1.5h.A repeat treatment was administered once weekly for a maximum of 3 weeks.

Outcomes

Primary Outcome Measures

The clearance rate of Moderate or Severe Acne
The clearance rate of Moderate or Severe Acne will be measured at one month after the last treatment

Secondary Outcome Measures

Pain assessment
The pain will be assessed using Visual Analogue Scale#VAS) 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 min, 3rd min, 5th min, 7th min, 10th min and 2nd h, 12th h, 24th h and 48th h after treatment.

Full Information

First Posted
May 19, 2019
Last Updated
May 21, 2019
Sponsor
Shanghai Dermatology Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03961607
Brief Title
Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Moderate or Severe Acne
Official Title
Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Moderate or Severe Acne#a Randomized, Open-label Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 10, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Dermatology Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
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 aminolevulinic acid photodynamic therapy#ALA- PDT) to a conventional regimen for treatment of Moderate or Severe Acne. The hypothesis is that the continuous illumination approach will be less or even no painful, but equally efficacious, as the old regimen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
Keywords
Photodynamic Therapy, Conventional, Painless, Acne

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Evaluator assesses photographs without prior knowledge of intervention
Allocation
Randomized
Enrollment
20 (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 3 weeks.
Arm Title
Conventional Photodynamic Therapy(C-PDT) group
Arm Type
Active Comparator
Arm Description
The conventional photodynamic therapy(C-PDT) group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 50 J/cm2) after applying 5% 5-aminolevulinic acid cream for 1.5h.A repeat treatment was administered once weekly for a maximum of 3 weeks.
Intervention Type
Procedure
Intervention Name(s)
Aminolevulinic acid photodynamic therapy
Intervention Description
Aminolevulinic acid photodynamic therapy
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 one month after the last treatment
Time Frame
The clearance rate of Moderate or Severe Acne will be measured at one month after the last treatment
Secondary Outcome Measure Information:
Title
Pain assessment
Description
The pain will be assessed using Visual Analogue Scale#VAS) 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 min, 3rd min, 5th min, 7th min, 10th min and 2nd h, 12th h, 24th h and 48th h after treatment.
Time Frame
Immediately, 1st minute, 3rd minute, 5th minute, 7th minute, 10th minute and 2 hours, 12 hours, 24hours and 48 hours after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosed with moderate to severe acne; Male and female patients of age between 18-30 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 surgery for various reasons,unwilling to undergo surgery, 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 People with sexual coagulopathy; Those with severe neurological, psychiatric or endocrine diseases; (10)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
Yunfeng Zhang, MD
Phone
+86-18017336550
Email
yunfeng0519116@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Haiyan Zhang, MD
Phone
+86-18017336573
Email
zhanghaiyan10842@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiuli Wang, PhD, MD
Organizational Affiliation
Shanghai Skin Disease Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Yunfeng Zhang
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200443
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunfeng Zhang, MD
Email
yunfeng0519116@aliyun.com
First Name & Middle Initial & Last Name & Degree
Haiyan Zhang, MD
Email
zhanghaiyan10842@163.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

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Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Moderate or Severe Acne

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