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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.
The acne clinical guidelines all recommend PDT as an alternative therapy for moderate to severe acne based on the excellent performance of ALA-PDT in the treatment of acne vulgaris. Photosensitizers including Porphyrin and Chlorin have also proved to play a positive role in reducing the number of skin lesions and microbial load. Researchers have successfully provided basic evidence that Chlorin-e6 induces inflammation inhibition through AP-1, NF-κB, MAPKs and other pathways of propionibacterium acnes and increases collagen expression in HaCaT cells, which undoubtedly further indicates: As a new type of photosensitive material, Chlorin-e6 derivatives have excellent performance in the face of moderate and severe acne with high levels of inflammation and high risk of scar.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| photosensitizer group | Experimental | Subjects will receive a photodynamic therapy with chlorin-e6 after acne removal surgery.Each subject will receive three treatments, two weeks (±3 days) intervals. |
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| photosensitizer-placebo group | Placebo Comparator | Subjects will receive a red light exposure treatment with chlorin-e6 placebo after acne removal surgery.Each subject will receive three treatments, two weeks (±3 days) intervals. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-chlorin e6 triglumine | Drug | a photodynamic therapy with chlorin-e6 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 2 weeks/1 month/2 month/6 month after final treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 2 weeks/1 month/2 month/6 month after final treatment |
| Change in Acne-specific Quality of Life Assessment Instrument(Qol-Acne)Relative to Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huiyan Chi, doctor | Contact | 13811626953 | chihuiyan@163.com | |
| Yisheng Zhang, doctor | Contact | 15652386117 | llleera@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Huiyan Chi, doctor | Deputy director of dermatology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiyuan Hospital of China Academy of Chinese Medical Sciences Organization | Recruiting | Beijing | 100091 | China |
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2024.1-2026.9
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| acne removal surgery | Procedure | acne removal surgery will be given before red light exposure |
|
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. |
| Baseline and 2 weeks/1 month/2 month/6 month after final treatment |
| 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. | 5 minutes after the start of red light exposure and Immediately after the treatment |
| 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. | Baseline and 2 weeks after final treatment |
| Change in Adverse Reaction Management Form(AR-MF) Relative to Baseline | Adverse Reaction Management Form will be used to systemically investigate the adverse reactions relating to ALA-PDT for acne vulgaris,which including erythema , post-treatment pain, burning skin, dry skin, itching , pustule , edema and blister, or recovery-phase adverse reactions, which included crust, exudation and hyperpigmentation. | Baseline and 2 weeks/1 month/2 month/6 month after final treatment |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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