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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04213638
• Other study ID #: 1120191113
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2019
• Est. completion date: November 2020

Study information

• Verified date: December 2019
• Source: Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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."

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."

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Xiang Ya Hospital Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. 2019 Sep 10. doi: 10.1002/lsm.23152. [Epub ahead of print] — View 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. Review. — View 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. 2019 Oct 25. doi: 10.1111/jocd.13197. [Epub ahead of print] Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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