Clinical trial NCT03961607: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Acne
Keywords: Photodynamic Therapy
Conventional
Painless
Acne
Lead sponsor: Shanghai Dermatology Hospital
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The clearance rate of Moderate or Severe Acne
timeFrame: The clearance rate of Moderate or Severe Acne will be measured at one month after the last treatment
Secondary outcomes:
measure: Pain assessment
timeFrame: Immediately, 1st minute, 3rd minute, 5th minute, 7th minute, 10th minute and 2 hours, 12 hours, 24hours and 48 hours after treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Yunfeng Zhang
state: Shanghai
Study officials:
affiliation: Shanghai Skin Disease Hospital
name: Xiuli Wang, PhD, MD
role: STUDY_CHAIR
References: