Rosacea
Conditions
Keywords
Rosacea
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.
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.
Sponsors
Second Affiliated Hospital of Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The range, quantity and degree of facial erythema | 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 | 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 | Before the first treatment, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks | The skin non-invasive detector conducts the test. |
| MI | 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 | 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 | Before the first treatment, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks | The skin non-invasive detector conducts the test. |
| Skin elasticity | Before the first treatment, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks | The skin non-invasive detector conducts the test. |
Countries
China
Outcome results
None listed