Evaluating a new light-based treatment for moderate to severe acne

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

This study is testing a new light-based treatment for moderate to severe acne to see if it can help clear up skin and reduce scarring.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06311890 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy, safety, and tolerability of photodynamic therapy using Chlorin-e6 for treating moderate to severe acne. The therapy is based on the premise that Chlorin-e6 can effectively reduce skin lesions and microbial load while inhibiting inflammation. Participants will receive treatment and be monitored for their response to the therapy, with a focus on its potential to improve acne symptoms and reduce scarring. The study aims to provide evidence supporting the use of this new photosensitizer in clinical practice.

Who should consider this trial

Good fit: Ideal candidates are males or non-pregnant females aged 18 to 50 with moderate to severe facial acne vulgaris.

Not a fit: Patients who are taking photosensitive drugs or have a history of allergies to the components of the photosensitizer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients suffering from moderate to severe acne.

How similar studies have performed: Previous studies have shown positive results with photodynamic therapy for acne, suggesting that this approach may be effective.

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.

Where this trial is running

Beijing

• Xiyuan Hospital of China Academy of Chinese Medical Sciences Organization — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Huiyan Chi, doctor

Conditions Acne; Photodynamic Therapy