NCT06311890 Study to Evaluate the Efficacy, Safety and Tolerability of Photodynamic Therapy(PDT) With Chlorin-e6 in Treating Moderate to Severe Acne
| NCT ID | NCT06311890 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Xiyuan Hospital of China Academy of Chinese Medical Sciences |
| Condition | Acne |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 46 participants in total. It began in 2024-02-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Huiyan Chi, doctor
STUDY DIRECTOR
Deputy director of dermatology
Frequently Asked Questions
Who can join the NCT06311890 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Acne. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06311890 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06311890 currently recruiting?
Yes, NCT06311890 is actively recruiting participants. Contact the research team at chihuiyan@163.com for enrollment information.
Where is the NCT06311890 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06311890 clinical trial?
NCT06311890 is sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences. The principal investigator is Huiyan Chi, doctor at Deputy director of dermatology. The trial plans to enroll 46 participants.