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Clinical Trials in China / NCT06311890
Recruiting Phase 2

Study to Evaluate the Efficacy, Safety and Tolerability of Photodynamic Therapy(PDT) With Chlorin-e6 in Treating Moderate to Severe Acne

NCT06311890 · tracked via the Priya Life Science China tracker
Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Phase
Phase 2
Started
2024-02-01
Last updated
2024-03-15

Condition(s) studied

AcnePhotodynamic Therapy

Investigational drug(s) / intervention(s)

N-chlorin e6 triglumineacne removal surgery

N-chlorin e6 triglumine: a photodynamic therapy with chlorin-e6

acne removal surgery: acne removal surgery will be given before red light exposure

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Xiyuan Hospital of China Academy of Chinese Medical Sciences Organization Beijing China Recruiting

More Xiyuan Hospital of China Academy of Chinese Medical Sciences trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06311890 on ClinicalTrials.gov ↗ ← All trials in China