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

Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Moderate or Severe Acne#a Randomized, Open-label Trial

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.

Study Overview

• Status: Unknown
• Conditions: Acne
• Intervention / Treatment: Procedure: Aminolevulinic acid photodynamic therapy

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haiyan Zhang, MD; Phone Number: +86-18017336573; Email: zhanghaiyan10842@163.com
• Study Contact Backup: Name: Yunfeng Zhang, MD; Phone Number: +86-18017336550; Email: yunfeng0519116@aliyun.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200443
      • Recruiting
      • Yunfeng Zhang
      • Contact: Yunfeng Zhang, MD; Email: yunfeng0519116@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

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 3 weeks.	Procedure: Aminolevulinic acid photodynamic therapy; Aminolevulinic acid photodynamic therapy
ACTIVE_COMPARATOR: Conventional Photodynamic Therapy(C-PDT) group; 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.	Procedure: Aminolevulinic acid photodynamic therapy; Aminolevulinic acid photodynamic therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately, 1st minute, 3rd minute, 5th minute, 7th minute, 10th minute and 2 hours, 12 hours, 24hours and 48 hours after treatment

Collaborators and Investigators

• Sponsor: Shanghai Dermatology Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 10, 2019
• Primary Completion (ANTICIPATED): December 30, 2019
• Study Completion (ANTICIPATED): December 30, 2019

Study Registration Dates

• First Submitted: May 19, 2019
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (ACTUAL): May 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 23, 2019
• Last Update Submitted That Met QC Criteria: May 21, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Acne; Photodynamic Therapy; Conventional; Painless
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Photosensitizing Agents; Dermatologic Agents; Aminolevulinic Acid
• Other Study ID Numbers: 2019-10

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: 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