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Completed

NCT Number: NCT06969300

FMRF Combined With 30% SSA in the Treatment of Rosacea

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.

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Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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-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.

Primary outcomes

  1. The range, quantity and degree of facial erythema

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

    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.

  2. Erythema score

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

    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%

  3. TEWL

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

    The skin non-invasive detector conducts the test.

  4. MI

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

    The skin non-invasive detector conducts the test.

  5. L*a*b

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

    The skin non-invasive detector conducts the test.

  6. The moisture content of the stratum corneum

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

    The skin non-invasive detector conducts the test.

  7. Skin elasticity

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

    The skin non-invasive detector conducts the test.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Other

Registry information

Official study title

Efficacy and Safety Evaluation of Fractional Microneedling Radiofrequency Combined With 30% Supramolecular Salicylic Acid in the Treatment of Refractory Erythrotelangiectatic Rosacea

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 13, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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