FMRF Combined With 30% SSA in the Treatment of Rosacea

NCT06969300 | Completed

• 1 other identifier: MR-61-24-008032
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Rosacea

Keywords

Rosacea

Outcome Measures

Primary Outcomes (7)

• The range, quantity and degree of facial erythema

  After cleansing the face with Visia, take a rest for 30 minutes at room temperature of 25 degrees Celsius and then take frontal and lateral images.

  Before the first treatment, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks

• Erythema score

  Assessment of lesion morphology score: No visible erythema under natural light = 0 points; Mild erythema can be observed under natural light, presenting as pale red, not obvious at a distance of 50 cm, and can be covered by simple makeup or beard covering = 2 points; Moderate erythema can be observed under natural light, presenting as red, obvious at a distance of 50 cm, and simple makeup or beard covering is not sufficient to cover = 4 points; Severe erythema can be observed under natural light, presenting as bright red, still obvious at a distance of more than 50 cm, and simple makeup or beard covering is insufficient to cover = 6 points. Weighted coefficient for the number/area of lesions: 1-10/5%-10% = 1, 11-20/11%-20% = 2, \>20/20% = 3. Total score of lesion severity = Morphology score × Weighted coefficient. Based on the score, calculate the therapeutic index, therapeutic index = (Total score before treatment - Total score after treatment) / Total score before treatment × 100%

  Before the first treatment, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks

• TEWL

  The skin non-invasive detector conducts the test.

  Before the first treatment, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks

• MI

  The skin non-invasive detector conducts the test.

  Before the first treatment, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks

• L*a*b

  The skin non-invasive detector conducts the test.

  Before the first treatment, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks

• The moisture content of the stratum corneum

  The skin non-invasive detector conducts the test.

  Before the first treatment, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks

• Skin elasticity

  The skin non-invasive detector conducts the test.

  Before the first treatment, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks

Study Arms (2)

Gold micro-needling treatment

OTHER

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.

Device: Gold micro needles

Gold micro-needling combined with salicylic acid treatment

EXPERIMENTAL

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.

Drug: Gold micro-needles combined with salicylic acid

Interventions

Gold micro needles 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 treatment

Gold micro-needles combined with salicylic acid 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.

Gold micro-needling combined with salicylic acid treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• The therapeutic response to the medication is unsatisfactory and the condition is prone to relapse.
• Age range: 18 to 60 years old
• The patient voluntarily participated in this clinical study and signed the written informed consent form.

You may not qualify if:

• 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.
• Individuals who are allergic to the test drug or have hypersensitive constitution.
• Patients who are pregnant, about to become pregnant or are lactating.
• Patients with acne during the consultation.
• Patients who had undergone facial injections or surgeries within the past two months before the trial.
• Patients with immunodeficiency diseases and abnormal coagulation function.

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

Study Sites (1)

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

Location

MeSH Terms

Conditions

Rosacea

Interventions

Salicylic Acid

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 13, 2025
• Study Start: December 1, 2023
• Primary Completion: November 14, 2024
• Study Completion: November 14, 2024
• Last Updated: May 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)