Clinical trial NCT06969300: FMRF Combined With 30% SSA in the Treatment of Rosacea
Official title: Efficacy and Safety Evaluation of Fractional Microneedling Radiofrequency Combined With 30% Supramolecular Salicylic Acid in the Treatment of Refractory Erythrotelangiectatic Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rosacea
Keywords: Rosacea
Lead sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was a single-center, case-by-case, bilateral facial comparison study. A total of 15 patients were included. On the day of enrollment, after the completion of the test items, treatment was carried out (full face gold micro-needling + 30% salicylic acid on the half face), and on-site follow-up was conducted 1 week later, 2 weeks later follow-up was conducted and the second acid brushing treatment was performed, 4 weeks later follow-up was conducted and the third acid brushing treatment was performed, on-site follow-up was conducted at the 8th week and the 12th week, and the follow-up contents included: Visia photography, camera photography, non-invasive skin testing, questionnaire assessment, etc. The study duration was 12 weeks.

Detailed description: This study is a single-center case-control study with half-side face as the control group. According to the inclusion and exclusion criteria, 15 patients with rosacea (erythema and telangiectasia type) were included. Before and after treatment, various skin indicators of the patients were evaluated and followed up. Through screening, subjects who met all the inclusion criteria and did not violate any of the exclusion criteria would be included in this study. The researchers measured and evaluated the various skin indicators of the patients. On the day of enrollment, the project was completed and treatment was carried out (full face gold micro-needling + 30% salicylic acid on half-side face), and then on-site follow-up was conducted 1 week later, 2 weeks later, 4 weeks later, 8 weeks later, and 12 weeks later. The follow-up contents included: Visia photography, camera photography, non-invasive skin detection, questionnaire assessment, etc. The study duration was 12 weeks.

Eligibility criteria: Inclusion Criteria:

1. According to the latest diagnostic criteria of the American Rosacea Society (2017 version) - Annex 1, patients diagnosed with the main phenotype of erythema and telangiectasia.
2. The therapeutic response to the medication is unsatisfactory and the condition is prone to relapse.
3. Age range: 18 to 60 years old
4. The patient voluntarily participated in this clinical study and signed the written informed consent form.

Exclusion Criteria:

1. The patient has other skin disorders on the face, such as melasma, freckles and seborrheic dermatitis, which may affect the judgment of the test results.
2. Individuals who are allergic to the test drug or have hypersensitive constitution.
3. Patients who are pregnant, about to become pregnant or are lactating.
4. Patients with acne during the consultation.
5. Patients who had undergone facial injections or surgeries within the past two months before the trial.
6. Patients with immunodeficiency diseases and abnormal coagulation function.

Primary outcomes:
measure: The range, quantity and degree of facial erythema
timeFrame: Before the first treatment, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks
measure: Erythema score
timeFrame: Before the first treatment, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks
measure: TEWL
timeFrame: Before the first treatment, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks
measure: MI
timeFrame: Before the first treatment, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks
measure: L*a*b
timeFrame: Before the first treatment, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks
measure: The moisture content of the stratum corneum
timeFrame: Before the first treatment, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks
measure: Skin elasticity
timeFrame: Before the first treatment, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Xian
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
References: