Trial of Single Microneedle Radiofrequency for Moderate-to-Severe Acne Vulgaris

Study Overview
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Brief Summary
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The purpose of the study is to testify the efficacy of treating moderate-to-severe acne vulgaris with Single Microneedle Radiofrequency, and provide evidence for the hypothesis that whether Single Microneedle Radiofrequency therapy could be an alternative to photodynamic therapy for moderate to severe acne vulgaris.

Detailed Description
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The purpose of the study is to testify whether Single Microneedle Radiofrequency is effective for moderate-to-severe acne vulgaris, through treating moderate-to-severe acne vulgaris patient for 1 month, using photodynamic therapy as controlled group, and try to provide clinical evidence for the hypothesis that whether Single Microneedle Radiofrequency therapy could be an alternative to photodynamic therapy for moderate to severe acne vulgaris.

Official Title
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Randomized Controlled Trial of Single Microneedle Radiofrequency for Moderate-to-Severe Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Other: Single Microneedle Radiofrequency therapy
* Other: Photodynamic therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consistent with the diagnostic criteria of moderate-to-severe acne vulgaris (IGA3-4) . Age of a subject is older than 14 and is younger than 45.（including 14 and 45）. Did not take any anti-acne treatment in the last 1 month, and did not take part in any clinical trial. Informed consent is signed by a subject or his lineal relation. Exclusion Criteria: systemic acne treatment with oral isotretinoin within 6 months or oral antibiotics in the past 1 month; history of facial procedures like dermabrasion, chemical, or laser peels; history of photosensitive diseases, porphyria, or porphyrin sensitivity. With serious protopathy or disease of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on. Pregnant women or women in lactation.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group：1<br>Intervention: Other：Single Microneedle Radiofrequency therapy | Other: Single Microneedle Radiofrequency therapy<br>* Subjects are treated with three consecutive sessions of Single Microneedle Radiofrequency therapy at 2-week intervals, with a follow-up visit 12 weeks after the final third treatment. Each treatment session took approximately 30-60 minutes.<br>|
| Active Comparator: Group：2<br>Intervention: Other：Photodynamic therapy | Other: Photodynamic therapy<br>* Subjects are treated with three consecutive sessions of Photodynamic therapy at 2-week intervals, with a follow-up visit 12 weeks after the final third treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The reduction rate of number of acne lesions | Measure the reduction rate of number of acne lesions at 16 weeks after treatment compared with a baseline | 16 weeks |