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

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

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."

Study Overview

• Status: Unknown
• Conditions: Acne Vulgaris
• Intervention / Treatment: Other: Single Microneedle Radiofrequency therapy; Other: Photodynamic therapy

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 Type: Interventional
• Enrollment (Anticipated): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410000
      • Recruiting
      • Xiang Ya Hospital Central South University
      • Contact: Dan Jian, Doctor; Phone Number: 18175103373; Email: mengping@csu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group：1; Intervention: Other：Single Microneedle Radiofrequency therapy	Other: Single Microneedle Radiofrequency therapy; 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.
Active Comparator: Group：2; Intervention: Other：Photodynamic therapy	Other: Photodynamic therapy; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University

Publications and helpful links

General Publications

• Lynn DD, Umari T, Dunnick CA, Dellavalle RP. The epidemiology of acne vulgaris in late adolescence. Adolesc Health Med Ther. 2016 Jan 19;7:13-25. doi: 10.2147/AHMT.S55832. eCollection 2016.
• Xing M, Yan X, Sun X, Wang S, Zhou M, Zhu B, Kuai L, Liu L, Luo Y, Li X, Li B. Fire needle therapy for moderate-severe acne: A PRISMA systematic review and meta-analysis of randomized controlled trials. Complement Ther Med. 2019 Jun;44:253-260. doi: 10.1016/j.ctim.2019.04.009. Epub 2019 Apr 28.
• Tang X, Li C, Ge S, Chen Z, Lu L. Efficacy of photodynamic therapy for the treatment of inflammatory acne vulgaris: A systematic review and meta-analysis. J Cosmet Dermatol. 2020 Jan;19(1):10-21. doi: 10.1111/jocd.13197. Epub 2019 Oct 25.
• Ahn GR, Kim JM, Park SJ, Li K, Kim BJ. Selective Sebaceous Gland Electrothermolysis Using a Single Microneedle Radiofrequency Device for Acne Patients: A Prospective Randomized Controlled Study. Lasers Surg Med. 2020 Jun;52(5):396-401. doi: 10.1002/lsm.23152. Epub 2019 Sep 10.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: December 26, 2019
• First Submitted That Met QC Criteria: December 27, 2019
• First Posted (Actual): December 30, 2019

Study Record Updates

• Last Update Posted (Actual): December 30, 2019
• Last Update Submitted That Met QC Criteria: December 27, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: 1120191113

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No