Actively Recruiting
Study to Evaluate the Efficacy, Safety and Tolerability of Photodynamic Therapy(PDT) With Chlorin-e6 in Treating Moderate to Severe Acne
Led by Xiyuan Hospital of China Academy of Chinese Medical Sciences · Updated on 2024-03-15
46
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical efficacy, safety, and tolerability of a new photodynamic therapy (PDT) using Chlorin-e6 for treating moderate to severe acne. This study is based on evidence that PDT, especially with photosensitizers like Porphyrin and Chlorin, can reduce skin lesions and microbial load. Chlorin-e6 has shown promise in reducing inflammation and increasing collagen in skin cells, suggesting its potential benefit for acne with high inflammation and scarring risk. Participants will receive acne removal surgery followed by three treatments spaced two weeks apart (plus or minus 3 days). One group will get PDT with Chlorin-e6, and the other will receive a placebo treatment with red light exposure and a chlorin-e6 placebo after surgery. Treatments focus on evaluating the photosensitizer's effects compared to placebo. During the study, researchers will assess changes using the Global Acne Grading System (GAGS) at baseline and multiple follow-up times up to six months after the final treatment. Participants will be monitored for safety, tolerability, and treatment adherence throughout. The study includes a randomized, quadruple-masked design and spans from screening to 6 months post-treatment, with ongoing evaluation of acne severity and participant wellbeing.
CONDITIONS
Brief Title
Study to Evaluate the Efficacy, Safety and Tolerability of Photodynamic Therapy(PDT) With Chlorin-e6 in Treating Moderate to Severe Acne
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is male or non-pregnant female aged 18 to under 50 years
- Subject has moderate to severe facial acne vulgaris
- Subject has provided written informed consent
You will not qualify if you...
- Taking photosensitive drugs
- Allergic to any component of the photosensitizer
- Allergies to porphyrins or history of photosensitivity
- Pregnant or lactating women, or planning pregnancy within 3 months
- Use of oral or topical antibiotics, retinoids, glucocorticoids, peroxybenzoyl, or similar drugs within past 1 month
- Exposure to sunlight in past 1 month, photoelectric treatment in past 3 months, or facial grinding treatment in past 6 months
- Using vasodilators, beta blockers, anticoagulants, or drugs causing facial capillary dilation
- Facial rosacea, atopic dermatitis, hormone-dependent dermatitis, or other facial skin diseases
- Abnormal blood or urine tests, liver/kidney dysfunction, important organ diseases, or hematopoietic system disorders
- Participation in other clinical trials concurrently
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo acne removal surgery before receiving photodynamic therapy or placebo treatment.
1 visit (in-person)
Duration - Approximately 6 weeks
Participants receive three photodynamic therapy or placebo treatments with chlorin-e6 at two-week intervals after surgery.
3 treatment visits (in-person) spaced two weeks apart
Duration - 6 months after final treatment
Participants are monitored with assessments of acne severity at 2 weeks, 1 month, 2 months, and 6 months after the final treatment.
4 follow-up visits (in-person)
Trial Site Locations
Total: 1 location
1
Xiyuan Hospital of China Academy of Chinese Medical Sciences Organization
Beijing, China, 100091
Actively Recruiting
Research Team
H
Huiyan Chi, doctor
Y
Yisheng Zhang, doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here