RosaceaNCT06969300
FMRF Combined With 30% SSA in the Treatment of Rosacea
A study testing Gold micro needles and Gold micro-needles combined with salicylic acid in people with Rosacea, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rosacea
- What is being tested?
- Gold micro needles and Gold micro-needles combined with salicylic acid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 14 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000
About this study
Official title: Efficacy and Safety Evaluation of Fractional Microneedling Radiofrequency Combined With 30% Supramolecular Salicylic Acid in the Treatment of Refractory Erythrotelangiectatic 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.
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.
- Conditions
- Rosacea
- Being tested
- Gold micro needles, Gold micro-needles combined with salicylic acid
- Keywords
- Rosacea
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gold micro needlesDevice
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 acidDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Gold micro-needles combined with salicylic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%
Measured: Before the first treatment, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks
TEWL
The skin non-invasive detector conducts the test.
Measured: Before the first treatment, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks
MI
The skin non-invasive detector conducts the test.
Measured: 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.
Measured: 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.
Measured: Before the first treatment, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Skin elasticity
The skin non-invasive detector conducts the test.
Measured: Before the first treatment, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Dec 2023
- Primary completion14 Nov 2024
- Study completion14 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weihui Zeng, Second Affiliated Hospital of Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969300
- Sponsor's protocol ID
- MR-61-24-008032
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 13 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Fractional Microneedling Radiofrequency Combined With 30% Supramolecular Salicylic Acid in the Treatment of Refractory Erythrotelangiectatic Rosacea
- ClinicalTrials.gov ID
- NCT06969300
- Acronym / sponsor ID
- MR-61-24-008032
- Conditions
- Rosacea
- Keywords
- Rosacea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 14 Nov 2024 (actual)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gold micro-needling treatment | Other | Device: Gold micro needlesThe 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 | Experimental | Drug: Gold micro-needles combined with salicylic acidOn 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gold micro needlesThe 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-needling treatment |
| Gold micro-needles combined with salicylic acidOn 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. | Drug | Gold micro-needling combined with salicylic acid treatment |
Primary outcome
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.
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%
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gold micro needles and Gold micro-needles combined with salicylic acid in people with Rosacea, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The range, quantity and degree of facial erythema (time frame: Before the first treatment, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.