Clinical trial NCT06311890: Study to Evaluate the Efficacy, Safety and Tolerability of Photodynamic Therapy(PDT) With Chlorin-e6 in Treating Moderate to Severe Acne
Official title: Study to Evaluate the Efficacy, Safety and Tolerability of Photodynamic Therapy(PDT) With Chlorin-e6 in Treating Moderate to Severe Acne
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Acne
Photodynamic Therapy
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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 outcomes:
measure: Change in Global Acne Grading System (GAGS) Relative to Baseline
timeFrame: Baseline and 2 weeks/1 month/2 month/6 month after final treatment
Secondary outcomes:
Other outcomes:
measure: Change in Inflammatory&non-inflammatory Lesion Counts Relative to Baseline
timeFrame: Baseline and 2 weeks/1 month/2 month/6 month after final treatment
measure: Change in Acne-specific Quality of Life Assessment Instrument（Qol-Acne）Relative to Baseline
timeFrame: Baseline and 2 weeks/1 month/2 month/6 month after final treatment
measure: Change in Numerical Rating Scale(NRS) Relative to Baseline
timeFrame: 5 minutes after the start of red light exposure and Immediately after the treatment
measure: Number of participants with abnormalities of Hematological Parameters and Urine Parameters Relative to Baseline
timeFrame: Baseline and 2 weeks after final treatment
measure: Change in Adverse Reaction Management Form(AR-MF) Relative to Baseline
timeFrame: Baseline and 2 weeks/1 month/2 month/6 month after final treatment
Locations:
city: Beijing
country: China
facility: Xiyuan Hospital of China Academy of Chinese Medical Sciences Organization
Study officials:
affiliation: Deputy director of dermatology
name: Huiyan Chi, doctor
role: STUDY_DIRECTOR
References: