RecruitingPhase 2NCT06311890

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

Sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Enrollment

46 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Acne Photodynamic Therapy

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

Min Age: 18 YearsMax Age: 50 Years

Inclusion Criteria3

Subject is male or non-pregnant female 18 years of age and younger than 50 years of age.
Subject has moderate to severe facial acne vulgaris.
Subject has provided written informed consent.

Exclusion Criteria10

People who are taking photosensitive drugs;
Allergic to any component of the photosensitizer;
porphyrins or allergies to porphyrins, with a history of photosensitivity;
Pregnant or lactating women and those planning to become pregnant within 3 months;
Oral or topical antibiotics, retinoids, glucocorticoids, peroxybenzoyl and other drugs within the past 1 month;
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;
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;
Patients with facial rosacea, atopic dermatitis, hormone-dependent dermatitis and other facial skin-related diseases;
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;
Patients participating in other clinical trials at the same time.