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

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ClinicalTrials.gov Identifier: NCT03961607
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Xiuli Wang, Shanghai Dermatology Hospital

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.

Condition or disease Intervention/treatment Phase
Acne Procedure: Aminolevulinic acid photodynamic therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Evaluator assesses photographs without prior knowledge of intervention
Primary Purpose: Treatment
Official Title: Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Moderate or Severe Acne#a Randomized, Open-label Trial
Actual Study Start Date : May 10, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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




Primary Outcome Measures :
  1. The clearance rate of Moderate or Severe Acne [ Time Frame: 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 :
  1. Pain assessment [ Time Frame: Immediately, 1st minute, 3rd minute, 5th minute, 7th minute, 10th minute and 2 hours, 12 hours, 24hours and 48 hours after treatment ]
    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.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961607


Contacts
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Contact: Yunfeng Zhang, MD +86-18017336550 yunfeng0519116@aliyun.com
Contact: Haiyan Zhang, MD +86-18017336573 zhanghaiyan10842@163.com

Locations
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China, Shanghai
Yunfeng Zhang Recruiting
Shanghai, Shanghai, China, 200443
Contact: Yunfeng Zhang, MD       yunfeng0519116@aliyun.com   
Contact: Haiyan Zhang, MD       zhanghaiyan10842@163.com   
Principal Investigator: Xiuli Wang, PhD, MD         
Sponsors and Collaborators
Shanghai Dermatology Hospital
Investigators
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Study Chair: Xiuli Wang, PhD, MD Shanghai Skin Disease Hospital

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Responsible Party: Xiuli Wang, Director, Clinical Professor, Shanghai Dermatology Hospital
ClinicalTrials.gov Identifier: NCT03961607     History of Changes
Other Study ID Numbers: 2019-10
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Clinical Study Report (CSR)
Time Frame: One year after finishing this study and for permanency
Access Criteria: anyone who search pubmed

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiuli Wang, Shanghai Dermatology Hospital:
Photodynamic Therapy
Conventional
Painless
Acne
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents