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CompletedNCT06969300Updated May 13, 2025

FMRF Combined With 30% SSA in the Treatment of Rosacea

An interventional study of Gold micro needles and Gold micro-needles combined with salicylic acid in Rosacea, sponsored by Second Affiliated Hospital of Xi'an Jiaotong University. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-13.

Sponsored by Second Affiliated Hospital of Xi'an Jiaotong University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Dec 2023, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Rosacea

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Keywords

  • Rosacea
03

In context

Rosacea

233 studies on the registry are indexed under Rosacea; 23 are open to participants now.

This study's enrollment of 15 is below the median of 61 across 200 interventional studies indexed under Rosacea.

Browse Rosacea studies →

Lead sponsor

Second Affiliated Hospital of Xi'an Jiaotong University is the lead sponsor of 70 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
15 participants (actual)

Study arms

  • Other
    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.

    Device: Gold micro needles

  • Experimental
    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.

    Drug: Gold micro-needles combined with salicylic acid

Interventions

  • DeviceGold 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.

  • DrugGold 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.

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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%

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

  3. TEWL

    The skin non-invasive detector conducts the test.

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

  4. MI

    The skin non-invasive detector conducts the test.

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

  5. L*a*b

    The skin non-invasive detector conducts the test.

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

  6. The moisture content of the stratum corneum

    The skin non-invasive detector conducts the test.

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

  7. Skin elasticity

    The skin non-invasive detector conducts the test.

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

07

Study locations

1 site
  • The Second Affiliated Hospital of Xi'an Jiaotong University
    Xian, Shaanxi 710000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06969300
Lead sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
Responsible party
Weihui Zeng (professor, Second Affiliated Hospital of Xi'an Jiaotong University) — Principal investigator
First posted
May 13, 2025
Start date
Dec 1, 2023
Primary completion
Nov 14, 2024
Completion
Nov 14, 2024
Last update
May 13, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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