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

Not Applicable

• Conditions: Acne Vulgaris
• Interventions: Other: Photodynamic therapy; Other: Single Microneedle Radiofrequency therapy

• Registration Number: NCT04213638
• Lead Sponsor: Xiangya Hospital of Central South University

Brief Summary

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

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."

Study Timeline

• Study Start: 2019-11-15
• Status Verified: 2019-12
• Study First Submitted: 2019-12-26
• Study First Submitted QC: 2019-12-27
• Last Update Submitted: 2019-12-27
• Study First Posted: 2019-12-30
• Last Update Posted: 2019-12-30
• Primary Completion: 2020-11
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

1. Consistent with the diagnostic criteria of moderate-to-severe acne vulgaris (IGA3-4) .
2. Age of a subject is older than 14 and is younger than 45.（including 14 and 45）.
3. Did not take any anti-acne treatment in the last 1 month, and did not take part in any clinical trial.
4. Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria

1. systemic acne treatment with oral isotretinoin within 6 months or oral antibiotics in the past 1 month;
2. history of facial procedures like dermabrasion, chemical, or laser peels;
3. history of photosensitive diseases, porphyria, or porphyrin sensitivity.
4. With serious protopathy or disease of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on.
5. Pregnant women or women in lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group：2	Photodynamic therapy	Intervention: Other：Photodynamic therapy
Group：1	Single Microneedle Radiofrequency therapy	Intervention: Other：Single Microneedle Radiofrequency therapy

Primary Outcome Measures

Name	Time	Method
The reduction rate of number of acne lesions	16 weeks	Measure the reduction rate of number of acne lesions at 16 weeks after treatment compared with a baseline

Trial Locations

Locations (1)

Xiang Ya Hospital Central South University; 🇨🇳 Changsha, Hunan, China