FMRF Combined With 30% SSA in the Treatment of Rosacea

NCT ID: NCT06969300

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-11-14

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.

Conditions

Rosacea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Gold micro-needling treatment

The treatment (with gold microneedles) was administered on the day of enrollment after the completion of the detection items. Follow-up visits were conducted at 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks. The follow-up contents included visia photography, camera photography, non-invasive skin examination, questionnaire assessment, etc. The study duration was 12 weeks.

Group Type: OTHER

Gold micro needles

Intervention Type: DEVICE

The treatment (with gold microneedles) was administered on the day of enrollment after the completion of the detection items. Follow-up visits were conducted at 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks. The follow-up contents included visia photography, camera photography, non-invasive skin examination, questionnaire assessment, etc. The study duration was 12 weeks.

Gold micro-needling combined with salicylic acid treatment

On the day of enrollment, the treatment was carried out after the completion of the detection items (gold microneedle + 30% salicylic acid on half of the face). A site follow-up was conducted one week later, and then follow-ups were conducted every two weeks for the second and third acid brushing treatments. Follow-up visits were also conducted every four weeks at the 8th and 12th weeks. The follow-up contents included: Visia photography, camera photography, non-invasive skin examination, questionnaire assessment, etc. The study duration was 12 weeks.

Group Type: EXPERIMENTAL

Gold micro-needles combined with salicylic acid

Intervention Type: DRUG

On the day of enrollment, the treatment was administered (gold microneedle + 30% salicylic acid on half of the face) after the completion of the detection items. A site follow-up was conducted one week later, and a follow-up was carried out two weeks later with the second acid brushing treatment. A follow-up was conducted four weeks later with the third acid brushing treatment. Follow-up was also conducted at the eighth and twelfth weeks. The follow-up contents included: Visia photography, camera photography, non-invasive skin examination, questionnaire assessment, etc. The study duration was 12 weeks.

Interventions

Gold micro needles

The treatment (with gold microneedles) was administered on the day of enrollment after the completion of the detection items. Follow-up visits were conducted at 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks. The follow-up contents included visia photography, camera photography, non-invasive skin examination, questionnaire assessment, etc. The study duration was 12 weeks.

Intervention Type: DEVICE

Gold micro-needles combined with salicylic acid

On the day of enrollment, the treatment was administered (gold microneedle + 30% salicylic acid on half of the face) after the completion of the detection items. A site follow-up was conducted one week later, and a follow-up was carried out two weeks later with the second acid brushing treatment. A follow-up was conducted four weeks later with the third acid brushing treatment. Follow-up was also conducted at the eighth and twelfth weeks. The follow-up contents included: Visia photography, camera photography, non-invasive skin examination, questionnaire assessment, etc. The study duration was 12 weeks.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Weihui Zeng

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

MR-61-24-008032

Identifier Type: -

Identifier Source: org_study_id