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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acne Photodynamic Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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photosensitizer group

Subjects will receive a photodynamic therapy with chlorin-e6 after acne removal surgery.Each subject will receive three treatments, two weeks (±3 days) intervals.

Group Type EXPERIMENTAL

N-chlorin e6 triglumine

Intervention Type DRUG

a photodynamic therapy with chlorin-e6

acne removal surgery

Intervention Type PROCEDURE

acne removal surgery will be given before red light exposure

photosensitizer-placebo group

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.

Group Type PLACEBO_COMPARATOR

acne removal surgery

Intervention Type PROCEDURE

acne removal surgery will be given before red light exposure

Interventions

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N-chlorin e6 triglumine

a photodynamic therapy with chlorin-e6

Intervention Type DRUG

acne removal surgery

acne removal surgery will be given before red light exposure

Intervention Type PROCEDURE

Other Intervention Names

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a red light irradiation

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No