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Clinical study on the efficacy and safety of an optical treatment method for rosacea

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099153
Enrollment
Unknown
Registered
2025-03-19
Start date
2025-01-13
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

The main clinical manifestations of rosacea are erythematous telangiectasia and/or papules and pustules

Interventions

Treatment group:Medical skin care hydrogel, Kroc Skin antibacterial gel, Kroc Hydroxypropyl ester antibacterial gel and photon therapeutic apparatus

Sponsors

Fifth Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1.Men or non pregnant women aged 18 to 45. Female participants of childbearing age need to undergo a urine pregnancy test during screening, and the result should be negative. 2.The main clinical manifestations of rosacea subjects are erythematous telangiectasia and/or papules and pustules. 3.Subjects with good cognitive function and normal mental state. 4.Can understand and comply with research requirements, and voluntarily sign informed consent forms.

Exclusion criteria

Exclusion criteria: 1.For medical skin care hydrogel, Kroc Skin antibacterial gel, Kroc Subjects allergic to any component in hydroxypropyl ester antibacterial gel. 2.History of systematic treatment with rosacea medication within the past month. 3.In the past month, there were topical drugs for rosacea, such as retinoic acid, azelaic acid, antibiotics, and benzoyl peroxide gel. 4. Have a history of facial beauty treatment within the past month, such as photoelectric equipment, chemical peels, exfoliation, etc. 5.Pregnant or breastfeeding women. Female participants are required to use at least one reliable and effective contraceptive method during the study period and within 30 days after the last treatment, such as barrier methods (condoms, uterine caps), intrauterine devices, or abstinence. 6.Subjects with a history of drug or alcohol abuse within the past 6 months, as determined by medical records or patient interviews. 7.Subjects with photosensitive skin diseases, such as polymorphic solar 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.Having a large amount of hair on the face can affect the assessment of light exposure or lesions in subjects. 11.Subjects who are unable to conduct research visits or are expected to have poor compliance. 12.Subjects with life-threatening diseases can affect their ability to complete research. 13.Participants who have participated in other clinical trial treatment studies within 30 days prior to the screening visit. 14.Subjects with a history of serious illnesses (such as malignant tumors, immune deficiencies or immune related diseases, liver and kidney dysfunction, cardiovascular disease history, endocrine system diseases, severe mental illnesses, drug or alcohol abuse history), infectious diseases involving facial lesions (such as syphilis, monkeypox, etc.), or any other situations that may make the subjects unsuitable for participation in the study in the eyes of the researchers. 15.Individuals with endocrine disorders or abnormal lifestyle habits (such as frequent staying up late and irregular diet). 16.Participants with unrealistic expectations.

Design outcomes

Primary

MeasureTime frame
Compliance rate of clinical erythema assessment scale (CEA) in subjects;

Secondary

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

Countries

China

Contacts

Public ContactHan Ma

Fifth Affiliated Hospital, Sun Yat-Sen University

drmahan@sina.com+86 756 2528182

Outcome results

None listed

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