Study to Evaluate the Efficacy, Safety and Tolerability of Photodynamic Therapy(PDT) With Chlorin-e6 in Treating Moderate to Severe Acne
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:
• Subject is male or non-pregnant female 18 years of age and younger than 50 years of age.
• Subject has moderate to severe facial acne vulgaris.
• Subject has provided written informed consent.
Locations
Other Locations
China
Xiyuan Hospital of China Academy of Chinese Medical Sciences Organization
RECRUITING
Beijing
Contact Information
Primary
Huiyan Chi, doctor
chihuiyan@163.com
13811626953
Backup
Yisheng Zhang, doctor
llleera@126.com
15652386117
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 46
Treatments
Experimental: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Xiyuan Hospital of China Academy of Chinese Medical Sciences