Acne Clinical Trial
Official title:
Study to Evaluate the Efficacy, Safety and Tolerability of Photodynamic Therapy(PDT) With Chlorin-e6 in Treating Moderate to Severe Acne
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.
Status | Recruiting |
Enrollment | 46 |
Est. completion date | September 30, 2026 |
Est. primary completion date | September 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: 1. Subject is male or non-pregnant female 18 years of age and younger than 50 years of age. 2. Subject has moderate to severe facial acne vulgaris. 3. Subject has provided written informed consent. Exclusion Criteria: 1. People who are taking photosensitive drugs; 2. Allergic to any component of the photosensitizer; 3. porphyrins or allergies to porphyrins, with a history of photosensitivity; 4. Pregnant or lactating women and those planning to become pregnant within 3 months; 5. Oral or topical antibiotics, retinoids, glucocorticoids, peroxybenzoyl and other drugs within the past 1 month; 6. Have a history of exposure to sunlight in the past 1 month, have received photoelectric treatment in the past 3 months, or have received facial grinding treatment in the past six months; 7. are using vasodilators (such as nitroglycerin, etc.), beta blockers (such as metoprolol, etc.), anticoagulants (such as warfarin, etc.) and other drugs that easily cause facial capillary dilatation; 8. Patients with facial rosacea, atopic dermatitis, hormone-dependent dermatitis and other facial skin-related diseases; 9. Abnormal blood and urine routine, liver and kidney function, diseases of important organs and hematopoietic system that researchers believe are not suitable for clinical trials; 10. Patients participating in other clinical trials at the same time. |
Country | Name | City | State |
---|---|---|---|
China | Xiyuan Hospital of China Academy of Chinese Medical Sciences Organization | Beijing |
Lead Sponsor | Collaborator |
---|---|
Xiyuan Hospital of China Academy of Chinese Medical Sciences |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | 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. | Baseline and 2 weeks/1 month/2 month/6 month after final treatment | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Primary | 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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