A Phase 2 interventional study of N-chlorin e6 triglumine and acne removal surgery in Acne and Photodynamic Therapy, sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences. Recruiting at 1 site in China. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences · Phase 2, Interventional, and Treatment
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.
790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.
This study's planned enrollment of 46 is below the median of 70 across 672 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Xiyuan Hospital of China Academy of Chinese Medical Sciences is the lead sponsor of 43 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive a photodynamic therapy with chlorin-e6 after acne removal surgery.Each subject will receive three treatments, two weeks (±3 days) intervals.
Drug: N-chlorin e6 triglumine · Procedure: acne removal surgery
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.
Procedure: acne removal surgery
a photodynamic therapy with chlorin-e6
Also known as: a red light irradiation
acne 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.
Time frame: Baseline and 2 weeks/1 month/2 month/6 month after final treatment
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.
Time frame: 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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 2 weeks/1 month/2 month/6 month after final treatment
Plan to share: Yes
Supporting information: Study protocol
Time frame: 2024.1-2026.9
Data sharing details ↗ · www.xyhospital.com
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Sep 2026, 31 months after the start.
Of 37 phase 2 interventional studies under Acne Vulgaris, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 15. This study's planned 31 months is above that.
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Xiyuan Hospital of China Academy of Chinese Medical Sciences