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Clinical study on the efficacy and safety of fluorescent light energy (FLE) in the treatment of rosacea

Clinical study on the efficacy and safety of fluorescent light energy (FLE) in the treatment of rosacea

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093683
Enrollment
Unknown
Registered
2024-12-10
Start date
2024-12-18
Completion date
Unknown
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rosacea

Interventions

Treatment group:Medical skin care hydrogel, Kolok ? skin antibacterial gel, and Kolok ? hydroxypropyl oxyphenyl antibacterial gel were evenly mixed according to the product instructions, and KBP was i

Sponsors

Sun Yat sen University Affiliated Fifth Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Male or non-pregnant female aged 18 to 45 years. Female subjects of childbearing potential are required to have a urine pregnancy test at screening and the result is negative; 2. Subjects with rosacea whose main clinical manifestations are erythematous telangiectasia and/or papulopustular vesicles; 3. Subjects with good cognitive function and normal mental state; 4. Able to understand and follow the requirements of the study and be able to voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Subjects who are allergic to any of the ingredients in medical skin care hydrogel, Kolok ® skin antibacterial gel, and Kolok ® hydroxypropyl oxyphenyl ester antibacterial gel; 2. History of systemic treatment of rosacea medication within the past month; 3. Topical medications for the treatment of rosacea within the past month, such as tretinoin, azelaic acid, antibiotics, benzoyl peroxide gel, etc.; 4. History of facial cosmetic treatments, such as photoelectric devices, chemical peels, exfoliation, etc., within the past month; 5. Females who are pregnant or breastfeeding. Female subjects need to use at least one reliable and effective method of contraception, such as barrier methods (condoms, diaphragms), intrauterine devices, or abstinence, during the study and for 30 days after the last treatment; 6. Subjects with a history of drug or alcohol abuse in the past 6 months, as determined by medical records or patient interviews; 7. Subjects with photosensitive skin diseases, such as polymorphic light rash, actinic keratosis, chronic photosensitive dermatitis, dermatomyositis, etc; 8. Subjects with a history of adverse reactions to light exposure; 9. Subjects with scars or infections in the treatment area; 10. Subjects with a large amount of facial hair that would affect light exposure or lesion assessment; 11. Subjects who are unable to attend the study visit or are expected to have poor compliance; 12. Subjects with life-threatening diseases that would affect their ability to complete the study; 13. Subjects who have participated in other clinical experimental treatment studies within 30 days prior to the screening visit; 14. Subjects with a history of serious diseases (such as malignant tumors, immunodeficiency or immune-related diseases, liver and kidney dysfunction, cardiovascular diseases, endocrine system diseases, severe psychiatric diseases, drug or alcohol abuse), infectious diseases involving facial lesions (such as syphilis, monkeypox, etc.), or any other conditions that would make the subject unsuitable for participating in the study in the opinion of the investigator; 15. Endocrine disorders, or abnormal lifestyle habits (such as frequent late nights, irregular diet); 16. Subjects with unrealistic expectations.

Design outcomes

Primary

MeasureTime frame
Clinician's Erythema Assessment, CEA;

Secondary

MeasureTime frame
Skin lesion count;Flushing Symptom Questionnaire,FSQ;Investigator’s Global Assessment,IGA;Detection indicators of CBS Cloud Mirror;Subject satisfaction evaluation;

Countries

China

Contacts

Public ContactHan Ma

Sun Yat sen University Affiliated Fifth Hospital

mhan@mail.sysu.edu.cn+86 131 2824 7946

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026