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

Primary Purpose

Acne Vulgaris

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Single Microneedle Radiofrequency therapy
Photodynamic therapy
Sponsored by
Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

14 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xiang Ya Hospital Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group：1

Group：2

Arm Description

Intervention: Other：Single Microneedle Radiofrequency therapy

Intervention: Other：Photodynamic therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 26, 2019
Last Updated
December 27, 2019
Sponsor
Xiangya Hospital of Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT04213638
Brief Title
Trial of Single Microneedle Radiofrequency for Moderate-to-Severe Acne Vulgaris
Official Title
Randomized Controlled Trial of Single Microneedle Radiofrequency for Moderate-to-Severe Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangya Hospital of Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group：1
Arm Type
Experimental
Arm Description
Intervention: Other：Single Microneedle Radiofrequency therapy
Arm Title
Group：2
Arm Type
Active Comparator
Arm Description
Intervention: Other：Photodynamic therapy
Intervention Type
Other
Intervention Name(s)
Single Microneedle Radiofrequency therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Photodynamic therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The reduction rate of number of acne lesions
Description
Measure the reduction rate of number of acne lesions at 16 weeks after treatment compared with a baseline
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Xiang Ya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Jian, Doctor
Phone
18175103373
Email
mengping@csu.edu.cn

12. IPD Sharing Statement

Citations:
PubMed Identifier
26955297
Citation
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.
Results Reference
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PubMed Identifier
31126563
Citation
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.
Results Reference
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PubMed Identifier
31654468
Citation
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.
Results Reference
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PubMed Identifier
31502662
Citation
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.
Results Reference
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Trial of Single Microneedle Radiofrequency for Moderate-to-Severe Acne Vulgaris

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