This study aims to evaluate the clinical efficacy, safety and tolerability of a photodynamic therapy(PDT) based on a new photosensitizer, Chlorin-e6, in the treatment of moderate to severe acne. The hypothesis is that the therapy has good efficacy, safety and tolerability.
Subject is male or non-pregnant female 18 years of age and younger than 50 years of age.
Subject has moderate to severe facial acne vulgaris.
Subject has provided written informed consent.
People who are taking photosensitive drugs;
Allergic to any component of the photosensitizer;
porphyrins or allergies to porphyrins, with a history of photosensitivity;
Pregnant or lactating women and those planning to become pregnant within 3 months;
Parallel
N-chlorin e6 triglumine
Druga photodynamic therapy with chlorin-e6
acne removal surgery
Procedure/Surgeryacne removal surgery will be given before red light exposure
Change in Global Acne Grading System (GAGS) Relative to Baseline
The Global Acne Grading System (GAGS) uses the grading score multiplied by the weight of the position, and the cumulative score is 1-18 for mild, 19-30 for moderate, 31-38 for severe, and above 39 for extremely severe.
Change in Inflammatory&non-inflammatory Lesion Counts Relative to Baseline
Acne, pimple, pustules, and nodules are classified as non-inflammatory and inflammatory in order to evaluate the efficacy of photodynamic anti-inflammatory.
Change in Acne-specific Quality of Life Assessment Instrument（Qol-Acne）Relative to Baseline
Self-perception, social functioning, and emotional functioning were recorded for the most recent week, with a score of 0-3 depending on the choice, with higher scores indicating worse impact of acne on quality of life.
Change in Numerical Rating Scale(NRS) Relative to Baseline
The NRS pain score is the digital pain score, which is used to assess the pain degree of the patient using the Digital Evaluation Scale of Pain Degree. The pain can be divided into different degrees according to the corresponding number, that is, 0 is no pain, 1-3 is mild pain, 4-6 is moderate pain, and 7-10 is severe pain. The higher the score, the higher the pain level and the greater the photodynamic side effects.
Number of participants with abnormalities of Hematological Parameters and Urine Parameters Relative to Baseline
white blood cell count,red blood cell count,haemoglobin,platelet count,ALT,AST,Cr andwhite blood cell count,red blood cell count,Protein in the urine. Clinical Complete blood cell analysis,Liver function,kidney function test and Clinical Urinalysiswill be used as the measurement tools of this result.Normal physiological parameters are regarded as the standard. If CREA is higher than normal after PDT or Protein in the urine is higher than normal, renal function may be impaired.If ALT or AST is higher than normal after PDT, liver function may be impaired.If the WBC is higher than normal after PDT, a systemic infection may be present.If RBC or Hb is lower than normal after PDT, anemia may be present.If PLT is lower than normal after PDT, a coagulopathy may be present.If WBC in the urine is higher than normal after PDT, a urinary tract infection may be present.If RBC in the urine is higher than normal after PDT, urological disorders may be present or coagulopathy may be present.
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