Xiyuan Hospital of China Academy of Chinese Medical Sciences Organization
Beijing, 100091, China
Location status: Recruiting
Location contact
Huiyan Chi, doctor
CONTACT
Yisheng Zhang, doctor
CONTACT
NCT Number: NCT06311890
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.
Interested in participating?
Request Info18 year–50 year
All sexes
Interventional
Phase 2
Beijing, 100091, China
Location status: Recruiting
Huiyan Chi, doctor
CONTACT
Yisheng Zhang, doctor
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
a photodynamic therapy with chlorin-e6
Other names: a red light irradiation
acne removal surgery will be given before red light exposure
Time frame: Baseline and 2 weeks/1 month/2 month/6 month after final treatment
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
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
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: 5 minutes after the start of red light exposure and Immediately after the treatment
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: Baseline and 2 weeks after final treatment
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/1 month/2 month/6 month after final treatment
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.
Contact information is provided by the study sponsor or research team.
Huiyan Chi, doctor
CONTACT
Yisheng Zhang, doctor
CONTACT
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06316297
Acne, Acne Vulgaris
Scottsdale, Arizona, United States
View Trial DetailsNCT07013747
Acne, Acne Vulgaris
Encino, California, United States
View Trial DetailsNCT06989840
Acne, Acne Vulgaris
Tempe, Arizona, United States
View Trial DetailsNCT07341087
Acne, Acne Vulgaris
London, United Kingdom
View Trial Details